NCT00827099 · REGISTRY CONDITION SEARCH

Umbilical Cord Blood (UCB) Transplant, Fludarabine, Melphalan, and Anti-thymocyte Globulin (ATG) in Treating Patients With 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: 2012-03-23

RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin works in treating patients with 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

Number of Participants With 100 Day Transplant-related Mortality (TRM)

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outcome · POSTED

Number of Patients That Engrafted Blood Counts by 30 Days After Transplant

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outcome · POSTED

Percentage of Donor and Host Chimerism of Each Cord Blood Unit

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outcome · POSTED

Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant.

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outcome · POSTED

Number of Patients Who Experience Disease Relapse Post-transplant

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outcome · POSTED

Number of Patients Who Survive Following Treatment on This Protocol

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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: DISEASE CHARACTERISTICS: * Diagnosis of hematologic malignancy for which a reduced-intensity allogeneic stem cell transplantation is deemed clinically appropriate, including any of the following: * Chronic myelogenous leukemia, meeting one of the following criteria: * In first chronic phase AND failed imatinib mesylate therapy, defined as failure to obtain a hematologic remission by 3 months or major cytogenetic response (Ph+ cells \< 35%) by 12 months, or demonstrated clonal evolution or disease progression while on therapy * In accelerated phase with \< 15% blasts * In blast crisis that has entered into a second chronic phase following induction chemotherapy * Acute myelogenous leukemia, meeting one of the following criteria: * In second or subsequent completion remission\* * Failed primary induction chemotherapy, but subsequently entered into a complete remission\* with ≤ 2 subsequent re-induction chemotherapy treatment(s) * In first complete remission\* with poor-risk cytogenetics NOTE: \*Complete remission is defined as \< 5% blasts in bone marrow, no definitive evidence of disease by morphology, flow cytometry, or genetic studies, and no circulating blasts. Neutrophil and platelet count recovery will not be required. * Acute lymphoblastic leukemia, meeting one of the following criteria: * In second or subsequent complete remission * In first complete remission AND t(9;22) * Myelodysplastic syndromes, meeting the following criteria: * High-risk disease, defined as International Prognostic Scoring System score of ≥ 1.5 * Less than 10% blasts at the time of study enrollment * Chronic myelomonocytic leukemia * Less than 10% blasts at the time of study enrollment * Myeloid metaplasia with myelofibrosis with poor-risk features, meeting one of the following criteria: * Age \< 55 years AND a Lille score of 1 * Lille score of 2 * Hemoglobin \< 10 g/dL AND abnormal karyotype * Chronic lymphocytic leukemia/prolymphocytic leukemia, meeting all of the following criteria: * Rai stage I-IV disease * Failed ≥ 1 prior chemotherapy regimen, including fludarabine, or autologous stem cell transplantation * Chemosensitive or stable, non-bulky disease prior to transplant * Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered prior regimens) * Low-grade B-cell non-Hodgkin lymphoma (NHL) (small lymphocytic lymphoma, follicular center \[grade 1 or 2\] lymphoma, or marginal zone lymphoma), meeting all of the following criteria: * Failed ≥ 1 prior chemotherapy regimen or autologous stem cell transplantation * Chemosensitive or stable, non-bulky disease prior to transplant * Received ≤ 3 prior chemotherapy regimens (monoclonal antibody therapy and involved-field radiotherapy are not considered prior regimens) * Intermediate-grade B-cell or T-cell NHL or mantle cell NHL, meeting all of the following criteria: * Failed to achieve remission or recurred after either conventional chemotherapy or autologous stem cell transplantation * Chemosensitive, non-bulky disease prior to transplant * Hodgkin lymphoma, meeting all of the following criteria: * Relapsed after prior autologous stem cell transplantation or after ≥ 2 combination chemotherapy regimens AND ineligible for autologous peripheral blood stem cell transplantation * Chemosensitive, non-bulky disease prior to transplant * Multiple myeloma, meeting one of the following criteria: * Relapsed after autologous stem cell transplantation * Relapsed after conventional therapies AND not a candidate for autologous stem cell transplantation * No HLA-matched related or unrelated donor available * Has two umbilical cord blood units available that are matched at ≥ 4/6 HLA A, B, and DRB1 with the patient and with each other (HLA C and DQ will not be used in the match strategy) * Total combined nucleated cell dose from the 2 umbilical cord blood units must be \> 3.7 x 10\^7 nucleated cells/kg (pre-freeze dose) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * Karnofsky performance status 80-100% * Adapted, weighted Charlson Comorbidity Index \< 3 * Serum creatinine ≤ 2.0 mg/dL * AST or ALT \< 3 times upper limit of normal (ULN) * Bilirubin \< 1.5 times ULN * Not pregnant or nursing * LVEF ≥ 40% * DLCO \> 50% * No hypoxia at rest with oxygen saturation \< 92% on room air (corrected with bronchodilator therapy) * No active opportunistic infection (e.g., fungal pneumonia, tuberculosis, or viral 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 HIV infection PRIOR CONCURRENT THERAPY: * See Disease Characteristics
healthy Volunteers: false
maximum Age: 65 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

interventions

description
anti-thymocyte globulin
name
anti-thymocyte globulin
type
BIOLOGICAL
description
fludarabine phosphate
name
fludarabine phosphate
type
DRUG
description
melphalan
name
Melphalan
type
DRUG
description
mycophenolate mofetil
name
mycophenolate mofetil
type
DRUG
description
tacrolimus
name
tacrolimus
type
DRUG
description
umbilical cord blood transplantation
name
umbilical cord blood transplantation
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 5
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
100 Day TRM is death within 100 days from transplant related complications
measure
Number of Participants With 100 Day Transplant-related Mortality (TRM)
time Frame
100 days

secondary Outcomes

description
Number of patients whose Absolute Neutrophil Count (ANC) recovered to \>500 x10\^3/uL for at least 3 consecutive days after transplant
measure
Number of Patients That Engrafted Blood Counts by 30 Days After Transplant
time Frame
Day 30
description
Evaluate the percentages of donor and host chimerism at multiple times post-transplant including Day 30, Day 60, Day 90 and monthly thereafter if the patient is not considered to have full chimerism.
measure
Percentage of Donor and Host Chimerism of Each Cord Blood Unit
time Frame
day 30, day 60, day 90
description
Patients will be evaluated regularly for the development of graft versus host disease both acute \& chronic.
measure
Number of Patients Who Experience Acute and Chronic Graft-vs-host Disease After Transplant.
time Frame
Day 30
description
Patients will have routine restaging to assess disease response at Day 100, 6 months, 1 year, 18 months and 24 months. If disease relapse is suspected, the patient will be evaluated at that time.
measure
Number of Patients Who Experience Disease Relapse Post-transplant
time Frame
Day 100, 6 months, 1 year, 18 months, 24 months
description
Patients will be followed until death
measure
Number of Patients Who Survive Following Treatment on This Protocol
time Frame
Through Death

Full study description

brief Summary: RATIONALE: Giving low doses of chemotherapy before a donor umbilical cord blood 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving umbilical cord blood transplant together with fludarabine, melphalan, and antithymocyte globulin works in treating patients with hematologic cancer.
detailed Description: OBJECTIVES: Primary * To evaluate the 100-day transplant-related (non-relapse) mortality in patients with hematologic malignancies undergoing reduced-intensity conditioning comprising fludarabine phosphate, melphalan, and anti-thymocyte globulin followed by sequential umbilical cord blood transplantation (UCBT) from 2 partially-matched unrelated donors. Secondary * To evaluate the 12-month transplant-related (non-relapse) mortality. * To evaluate the days to neutrophil engraftment (ANC \> 500/mm³). * To evaluate the days to platelet engraftment (platelet count \> 20,000/mm³ \[unsupported\]). * To evaluate the risk of acute and chronic graft-vs-host disease. * To evaluate percent donor chimerism contribution of each cord unit. * To evaluate relapse rate. * To evaluate disease-free and overall survival. * To evaluate transfusion support needed for UCBT recipients. OUTLINE: * Conditioning regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, melphalan IV over 30-60 minutes on day -2, and anti-thymocyte globulin IV over 4-6 hours on days -4 to -2. * Transplantation: Patients undergo two sequential umbilical cord blood transplantations on day 0. * Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously and then orally twice daily beginning on day -1 and continuing until day 60, followed by a taper until day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil IV or orally twice daily beginning on day 0 and continuing until day 30, followed by a taper until day 60 in the absence of GVHD. After completion of study treatment, patients are followed periodically.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice