NCT00818961 · REGISTRY CONDITION SEARCH

Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2013-12-18

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, such as alemtuzumab, before transplant and tacrolimus and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of donor stem cell transplant and to see how well it works in treating patients with high-risk hematologic cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Survival at Day 100

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outcome · POSTED

Overall Survival at 1 Year

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outcome · POSTED

Non-relapse Mortality at Day 100

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outcome · POSTED

Non-relapse Mortality at 1 Year Post-transplant

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outcome · POSTED

Complete Donor Chimerism

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outcome · POSTED

Neutrophil Recovery

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outcome · POSTED

Platelet Engraftment

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outcome · POSTED

Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism

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outcome · POSTED

Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant

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outcome · POSTED

Number of Patients Experiencing Chronic Graft Versus Host Disease

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outcome · POSTED

Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: * Diagnosis of one of the following hematological malignancies: * CML, with 1 of the following: * In first CP AND failed imatinib mesylate therapy, defined as failure to obtain a hematologic remission at 3 months or a major cytogenetic response (i.e., Ph+ cells \< 35%) at 6 months or demonstrated clonal evolution or disease progression during therapy * In accelerated phase with \< 15% blasts * In blast crisis that has entered into a second CP following induction chemotherapy * AML, with 1 of the following: * In second or subsequent complete remission (CR) (i.e., \< 5% blasts by morphology, no residual leukemia by flow cytometry, and absence of cytogenetic abnormalities) * Failed primary induction chemotherapy, but subsequently entered into a CR with ≤ 2 subsequent re-induction chemotherapy treatment(s) * In first CR with intermediate-risk or poor-risk cytogenetics * ALL with 1 of the following: * In second or subsequent CR * In first CR AND presence of t(9;22) * MDS, with the following: * High-risk disease, defined by IPSS score of ≥ 1.5 at diagnosis AND meets 1 of the following criteria: * ≤ 10% blasts at diagnosis * In morphologic CR (\< 5% blasts) following cytoreductive chemotherapy * CMML, with 1 of the following: * ≤ 10% blasts at diagnosis * In morphologic CR (\< 5% blasts) following cytoreductive chemotherapy * CLL/PLL with the following: * Rai stage I-IV disease * Failed ≥ 1 prior chemotherapy regimen (including fludarabine phosphate) or ASCT * Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as \< 20% bone marrow involvement AND lymph node size \< 3 cm in axial diameter * No bulky tumor masses, elevated lactate dehydrogenase (LDH), B symptoms, or progressive disease prior to transplant * Low-grade non-Hodgkin lymphoma (NHL) (i.e., small lymphocytic lymphoma, follicular center lymphoma \[grade 1 or 2\], marginal zone lymphoma, or B-cell lymphoma), with the following criteria: * Failed ≥ 1 prior chemotherapy regimen or ASCT * Documented chemosensitive or stable, non-bulky disease prior to transplant, defined as \< 20% bone marrow involvement AND lymph node size \< 3 cm in axial diameter * Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered a prior regimen) * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Mantle cell lymphoma, with the following: * Failed to achieve remission or recurred after either conventional chemotherapy or ASCT * Responsive or stable disease to most recent prior therapy * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Intermediate-grade NHL (i.e., follicular center lymphoma \[grade 3\] or diffuse large cell lymphoma), meeting the following criteria: * Failed to achieve remission or recurred after either conventional chemotherapy or ASCT * Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites) * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Hodgkin lymphoma, with the following: * Relapsed after prior ASCT OR after ≥ 2 combination chemotherapy regimens and ineligible for ASCT * Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites) * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Peripheral T-cell NHL, with the following: * Failed to achieve remission or recurred after either conventional chemotherapy or ASCT * Documented chemosensitive, non-bulky disease prior to transplant, defined as at least a partial remission to salvage chemotherapy (≥ 50% reduction in diameter of all disease sites) * No bulky tumor masses, elevated LDH, B symptoms, or progressive disease prior to transplant * Myeloproliferative syndrome with poor risk features, meeting 1 of the following criteria: * \< 55 years old AND Lille score of 1 * Lille score of 2 * HgB \< 10 g/dL AND abnormal karyotype * High-risk disease, with 1 of the following: * Age 40-72 years * Any age AND deemed to be at significantly increased risk of morbidity and death following a standard, myeloablative unrelated donor stem cell transplant (e.g., received extensive prior therapy, including ASCT) * HLA-matched unrelated donor available, with 1 of the following: * 8/8 match at HLA-A, B, C, or DR loci by high-resolution genotyping * Single allelic mismatch at either the HLA-B or HLA-C loci donor by high-resolution molecular typing * No single allelic mismatch at HLA-A or HLA-DR loci * KPS 80-100% * Adapted weighted Charlson Comorbidity Index \< 3 * Serum creatinine ≤ 2.0 mg/dL * AST or ALT \< 3 times upper limit of normal (ULN) * Total bilirubin \< 1.5 times ULN * LVEF ≥ 45% * DLCO \> 50% * No hypoxia at rest with oxygen saturation \< 92% on room air (corrected with bronchodilator therapy) * No other severe pulmonary function abnormalities * No HIV infection * No active hepatitis B or C infection that, in the opinion of a gastroenterologist or the transplant committee, places the patient at moderate to high risk for developing severe hepatic disease * No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral infection)
healthy Volunteers: false
maximum Age: 72 Years
minimum Age: 40 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on donor type
intervention Names
Biological: alemtuzumab
Biological: graft-versus-tumor induction therapy
Biological: rituximab
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
label
Hematopoietic Stem Cell Transplantation
type
OTHER

interventions

arm Group Labels
Hematopoietic Stem Cell Transplantation
description
43 mg subcutaneously over 3 days (3 mg on day -11, 10 mg on day -10, 30 mg on day -9)
name
alemtuzumab
other Names
Campath
type
BIOLOGICAL
arm Group Labels
Hematopoietic Stem Cell Transplantation
description
curative potential of allogeneic transplant results from the immune anti-tumor effect of donor cells or GVT/GVL
name
graft-versus-tumor induction therapy
type
BIOLOGICAL
arm Group Labels
Hematopoietic Stem Cell Transplantation
description
in patients with Cd20+ malignancies: rituximab 375 mg/m\*2 day -13. rituximab 1000 mg/m\*2 on days, -6, +1, +8.
name
rituximab
other Names
Rituxan
type
BIOLOGICAL
arm Group Labels
Hematopoietic Stem Cell Transplantation
description
For patients with AML, CML, MDS, MPS and ALL only: IV or oral busulfan may be given IV busulfan: 130 mg/m2 over 3 hours once daily on days -6, -5, -4 and -3 Oral busulfan: taken every 6 hours x 15 doses beginning on day -7 at 6pm and continuing through day -3 at 6am. 1 mg/kg test dose will be given prior to day -7 and PK samples will be drawn to calculate AUC.
name
busulfan
type
DRUG
arm Group Labels
Hematopoietic Stem Cell Transplantation
description
750 mg/m2 infused over 1 hour once daily on days -5, -4 and -3. Cyclophosphamide will be started approximately 4 hours after the start of Fludarabine
name
cyclophosphamide
other Names
Cytoxan
type
DRUG
arm Group Labels
Hematopoietic Stem Cell Transplantation
description
For patients with CLL, NHL \& HD: 30 mg/m2 infused over 30 minutes once daily on days -5, -4 and -3 For patients with AML, CML, MDS, MPS and ALL: 40 mg/m2 infused over 30 minutes once daily on days -6, -5, -4 and -3.
name
fludarabine phosphate
other Names
Fludara
type
DRUG
arm Group Labels
Hematopoietic Stem Cell Transplantation
description
5 mg/m2 administered on days +1, +3 and +6
name
methotrexate
type
DRUG
arm Group Labels
Hematopoietic Stem Cell Transplantation
description
0.03mg/kg/day infused over 24 hours starting on day -1 and switched to oral (twice daily divided dose) on day 14 or when able to tolerate PO
name
tacrolimus
other Names
Prograf; FK506
type
DRUG
arm Group Labels
Hematopoietic Stem Cell Transplantation
description
Recipients will receive an allogeneic transplant on day 0 after receiving high-dose chemotherapy. This trial uses matched unrelated donor stem cells.
name
allogeneic bone marrow transplantation
other Names
HSCT, allo transplant
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 36
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Survival at Day 100
measure
Survival at Day 100
time Frame
100 day

secondary Outcomes

description
Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant)
measure
Overall Survival at 1 Year
time Frame
1 year
description
patients are evaluable for their cause of death at Day 100
measure
Non-relapse Mortality at Day 100
time Frame
Day 100
description
Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive.
measure
Non-relapse Mortality at 1 Year Post-transplant
time Frame
1 year
description
Complete donor chimerism (defined as \>/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured.
measure
Complete Donor Chimerism
time Frame
2 years
description
The number of patients experiencing neutrophil recovery post transplant
measure
Neutrophil Recovery
time Frame
Day 100
description
The number of patients experiencing platelet engraftment post-transplant
measure
Platelet Engraftment
time Frame
Day 100
description
DLI is used for patients with mixed chimerism following transplant
measure
Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism
time Frame
Day 100
description
patients experiencing acute graft versus host disease post-transplant
measure
Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant
time Frame
patients were followed for 2 years
measure
Number of Patients Experiencing Chronic Graft Versus Host Disease
time Frame
>100 days post-transplant
description
Patients will be evaluated up to 4 years post transplant
measure
Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant
time Frame
4 years

Full study description

brief Summary: RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, such as alemtuzumab, before transplant and tacrolimus and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of donor stem cell transplant and to see how well it works in treating patients with high-risk hematologic cancer.
detailed Description: OBJECTIVES: * To evaluate the safety and toxicity of a reduced-intensity conditioning regimen followed by allogeneic bone marrow or peripheral blood stem cell transplantation from an HLA-matched unrelated donor in patients with high-risk hematologic malignancies. * To evaluate engraftment by peripheral blood chimerism analysis. * To determine the incidence and severity of acute and chronic graft-versus-host disease following the transplant. * To examine the possibility of controlling hematologic malignancies by induction of a graft-versus-leukemia/tumor effect. * To determine the disease-free survival, relapse, transplant-related mortality, and death from all causes. OUTLINE: * Reduced-intensity conditioning regimen: Patients receive 1 of 2 conditioning regimens according to diagnosis. * Regimen 1 (acute leukemia, myelodysplastic syndromes, myeloproliferative syndrome, or chronic myelogenous leukemia): Patients receive fludarabine phosphate IV over 30 minutes and busulfan IV over 3 hours on days -6 to -3 or orally 4 times daily on days -7 to -3. * Regimen 2 (lymphoproliferative malignancies): Patients receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 1 hour on days -5 to -3. Patients with CD20+ malignancies also receive rituximab IV over 4-6 hours on days -13, -6, 1, and 8. * Transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. * Graft-versus-host disease (GVHD) prophylaxis: Patients receive low-dose alemtuzumab subcutaneously on days -11 to -9 and tacrolimus IV over 24 hours beginning on day -3 and then orally twice daily beginning on day 14 and continuing until day 60, followed by a taper until day 180 in the absence of clinically significant GVHD. Patients also receive methotrexate on days 1, 3, and 6. Patients who exhibit persistent mixed chimerism or disease relapse/progression despite full withdrawal of immunosuppression may receive up to 3 donor lymphocyte infusions. Blood samples are taken on days 30, 60, and 100 and then every 4 weeks thereafter for chimerism studies by PCR analysis. After completion of study therapy, patients are followed periodically for up to 60 months.

Source references

references

citation
McGlave PB, Shu XO, Wen W, Anasetti C, Nademanee A, Champlin R, Antin JH, Kernan NA, King R, Weisdorf DJ. Unrelated donor marrow transplantation for chronic myelogenous leukemia: 9 years' experience of the national marrow donor program. Blood. 2000 Apr 1;95(7):2219-25.
pmid
10733488
type
BACKGROUND
citation
Sierra J, Storer B, Hansen JA, Martin PJ, Petersdorf EW, Woolfrey A, Matthews D, Sanders JE, Storb R, Appelbaum FR, Anasetti C. Unrelated donor marrow transplantation for acute myeloid leukemia: an update of the Seattle experience. Bone Marrow Transplant. 2000 Aug;26(4):397-404. doi: 10.1038/sj.bmt.1702519.
pmid
10982286
type
BACKGROUND
citation
Weisdorf DJ, Billett AL, Hannan P, Ritz J, Sallan SE, Steinbuch M, Ramsay NK. Autologous versus unrelated donor allogeneic marrow transplantation for acute lymphoblastic leukemia. Blood. 1997 Oct 15;90(8):2962-8.
pmid
9376576
type
BACKGROUND
citation
Anderson JE, Anasetti C, Appelbaum FR, Schoch G, Gooley TA, Hansen JA, Buckner CD, Sanders JE, Sullivan KM, Storb R. Unrelated donor marrow transplantation for myelodysplasia (MDS) and MDS-related acute myeloid leukaemia. Br J Haematol. 1996 Apr;93(1):59-67. doi: 10.1046/j.1365-2141.1996.4811022.x.
pmid
8611476
type
BACKGROUND
citation
Izutsu K, Kanda Y, Ohno H, Sao H, Ogawa H, Miyazaki Y, Kawa K, Kodera Y, Kato S, Morishima Y, Hirai H; Japan Marrow Donor Program. Unrelated bone marrow transplantation for non-Hodgkin lymphoma: a study from the Japan Marrow Donor Program. Blood. 2004 Mar 1;103(5):1955-60. doi: 10.1182/blood-2003-03-0937. Epub 2003 Nov 6.
pmid
14604976
type
BACKGROUND
citation
Shaw BE, Peggs K, Bird JM, Cavenagh J, Hunter A, Alejandro Madrigal J, Russell NH, Sirohi B, Towlson K, Williams CD, Marks DI; Clinical Trials Committee of the British Society of Blood and Marrow Transplantation. The outcome of unrelated donor stem cell transplantation for patients with multiple myeloma. Br J Haematol. 2003 Dec;123(5):886-95. doi: 10.1046/j.1365-2141.2003.04714.x.
pmid
14632780
type
BACKGROUND
citation
Davies SM, Kollman C, Anasetti C, Antin JH, Gajewski J, Casper JT, Nademanee A, Noreen H, King R, Confer D, Kernan NA. Engraftment and survival after unrelated-donor bone marrow transplantation: a report from the national marrow donor program. Blood. 2000 Dec 15;96(13):4096-102.
pmid
11110679
type
BACKGROUND
citation
Hansen JA, Gooley TA, Martin PJ, Appelbaum F, Chauncey TR, Clift RA, Petersdorf EW, Radich J, Sanders JE, Storb RF, Sullivan KM, Anasetti C. Bone marrow transplants from unrelated donors for patients with chronic myeloid leukemia. N Engl J Med. 1998 Apr 2;338(14):962-8. doi: 10.1056/NEJM199804023381405.
pmid
9521984
type
BACKGROUND
citation
Sorror ML, Maris MB, Storer B, Sandmaier BM, Diaconescu R, Flowers C, Maloney DG, Storb R. Comparing morbidity and mortality of HLA-matched unrelated donor hematopoietic cell transplantation after nonmyeloablative and myeloablative conditioning: influence of pretransplantation comorbidities. Blood. 2004 Aug 15;104(4):961-8. doi: 10.1182/blood-2004-02-0545. Epub 2004 Apr 27.
pmid
15113759
type
BACKGROUND
citation
Sullivan KM, Weiden PL, Storb R, Witherspoon RP, Fefer A, Fisher L, Buckner CD, Anasetti C, Appelbaum FR, Badger C, et al. Influence of acute and chronic graft-versus-host disease on relapse and survival after bone marrow transplantation from HLA-identical siblings as treatment of acute and chronic leukemia. Blood. 1989 May 1;73(6):1720-8.
pmid
2653460
type
BACKGROUND
citation
Mehta J, Singhal S. Graft-versus-myeloma. Bone Marrow Transplant. 1998 Nov;22(9):835-43. doi: 10.1038/sj.bmt.1701459.
pmid
9827810
type
BACKGROUND
citation
Jones RJ, Ambinder RF, Piantadosi S, Santos GW. Evidence of a graft-versus-lymphoma effect associated with allogeneic bone marrow transplantation. Blood. 1991 Feb 1;77(3):649-53.
pmid
1991174
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice