NCT00040846 · REGISTRY CONDITION SEARCH

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

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: COMPLETED
Registry last update: 2020-01-29

This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood 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. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.

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

Evaluate the Risk of Transplant Related Mortality.

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outcome · POSTED

Evaluate the Risk of Occurrence of Acute and Chronic GVHD

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outcome · POSTED

Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.

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outcome · POSTED

Evaluate the Risk/Incidence of Infections

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outcome · POSTED

Evaluate the Risk for Disease Progression and Relapse

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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: Inclusion Criteria: * Patients must be not eligible for conventional transplants and must have disease expected to be stable for at least 100 days without chemotherapy; patients with hematologic malignancies treatable with hematopoietic stem cell transplant (HSCT) or with a B cell malignancy except those treatable with autologous transplant will be included * Aggressive non-Hodgkin lymphomas (NHLs) and Other Histologies Such as Diffuse large B cell NHL * Patients with primary refractory or relapsed disease not eligible for an autologous transplant * Patients are eligible following an autologous transplant in remission or in relapse * Planned tandem transplant is allowed for patients at high risk of relapse * Low grade NHL with \< 6 months duration of complete remission (CR) between courses of conventional therapy * Mantle Cell NHL may be treated in first CR * Chronic lymphocytic leukemia (CLL) - Must have failed 2 lines of conventional therapy and be refractory to fludarabine * Hodgkin disease (HD) - Must have received and failed frontline therapy; patients must have had a prior autologous transplant or were not eligible for autologous transplant; planned tandem transplants are allowed for patients at high risk of relapse * Multiple myeloma (MM) - Must have received prior chemotherapy and a prior autologous transplant, unless autologous transplant was not possible; planned tandem transplants are allowed for patients at high risk of relapse * Acute myeloid leukemia (AML) - Must have \< 5% marrow blasts at the time of transplant * Acute lymphocytic leukemia (ALL) - Must have \< 5% blasts at the time of transplant * Chronic myeloid leukemia (CML) - Patients will be accepted beyond chronic phase 1 (CP1) if they have received previous myelosuppressive chemotherapy or HSCT, and have \< 5% marrow blasts at time of transplant * Myelodysplastic (MDS)/Myeloproliferative disorders - Must have failed previous myelosuppressive chemotherapy or HSCT, and have \< 5% marrow blasts at time of transplant * Waldenstrom's Macroglobulinemia - Must have failed 2 courses of therapy * Patients \< 12 years old must be approved by the Fred Hutchinson Cancer Research Center (FHCRC) principal investigator (PI) * Patients who refuse to be treated on a conventional transplant protocol; for this inclusion, criteria transplants must be approved by both the participating institution´s patient review committee such as the Patient Care Conference (PCC) at the FHCRC and the FHCRC principal investigator * Patients with related or unrelated donors for whom * The best available match is a HLA class II DRB1 and DQB1 matched donor incompatible for any single serologically detectable class I HLA-A, -B, -C mismatch; one additional allele level class I mismatch is allowed OR any combination of 2 allele level mismatches (if typed at the molecular level) * There is a likelihood of rapid disease progression while HLA typing and results of a preliminary search and the donor pool suggests that a 10/10 HLA-A, B, C, DRB1 and DQB1 matched unrelated donor will not be found * There is no HLA-A, -B or -C one locus allelic mismatched related donor available * There is no indication for an autologous transplantation as a treatment option * DONOR: Related or unrelated donors who are matched for HLA-DRB1 and DQB1 alleles (must be defined by high resolution typing), and who are mismatched for: * Any single serologically detectable HLA-A or B or C antigen +/- 1 allele or * Any combination of two HLA-A, -B, or -C alleles (if prospectively typed at molecular level) Exclusion Criteria: * Patients who are homozygous at the mismatched major histocompatibility complex (MHC) class I locus * A positive cross-match exists between the donor and recipient * Patients with rapidly progressive intermediate or high grade NHL * Presence of circulating leukemic blasts (in the peripheral blood) detected by standard pathology for patients with AML, ALL or CML * Life expectancy severely limited by diseases other than malignancy * Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy * Fertile men or women unwilling to use contraceptives during and for up to 12 months post treatment * Female patients who are pregnant or breast-feeding * Human immunodeficiency virus (HIV) positive patients * Patients with active non-hematologic malignancies (except non-melanoma skin cancers) * Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a \> 20% risk of disease recurrence * Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month * Patients with active bacterial or fungal infections unresponsive to medical therapy * Patients with the following organ dysfunction symptomatic coronary artery disease or ejection fraction \< 35% or other cardiac failure requiring therapy; ejection fraction is required if the patient is \> 50 years of age, or history of cardiac disease or anthracycline exposure * Diffusion capacity of carbon monoxide (DLCO) \< 35%; total lung capacity (TLC) \< 35%; or forced expiratory volume in one second (FEV1) \< 35% and/or receiving supplementary continuous oxygen * Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure; cirrhosis of the liver with evidence of portal hypertension; alcoholic hepatitis; esophageal varices; a history of bleeding esophageal varices; hepatic encephalopathy; uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time; ascites related to portal hypertension; bacterial or fungal liver abscess; biliary obstruction; chronic viral hepatitis with total serum bilirubin \>3 mg/dL; or symptomatic biliary disease * Patients with poorly controlled hypertension on multiple antihypertensives * Karnofsky score \< 70 for adult patients * Lansky-Play Performance Score \< 50 for pediatric patients * DONOR: Bone marrow (BM) donors * DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for granulocyte colony-stimulating factor (G-CSF) mobilization and harvest of peripheral blood stem cell (PBSC) * DONOR: Donors \< 12 years of age
healthy Volunteers: false
maximum Age: 74 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
CONDITIONING REGIMEN: Patients receive alemtuzumab IV over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156.
intervention Names
Biological: alemtuzumab
Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Drug: mycophenolate mofetil
Drug: cyclosporine
label
Treatment (dose-escalation of alemtuzumab, HSCT)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (dose-escalation of alemtuzumab, HSCT)
description
Given IV
name
alemtuzumab
other Names
anti-CD52 monoclonal antibody
Campath-1H
MoAb CD52
Monoclonal Antibody Campath-1H
Monoclonal Antibody CD52
type
BIOLOGICAL
arm Group Labels
Treatment (dose-escalation of alemtuzumab, HSCT)
description
Given IV
name
fludarabine phosphate
other Names
2-F-ara-AMP
Beneflur
Fludara
type
DRUG
arm Group Labels
Treatment (dose-escalation of alemtuzumab, HSCT)
description
Undergo TBI
name
total-body irradiation
other Names
TBI
type
RADIATION
arm Group Labels
Treatment (dose-escalation of alemtuzumab, HSCT)
description
Undergo allogeneic HSCT
name
allogeneic hematopoietic stem cell transplantation
type
PROCEDURE
arm Group Labels
Treatment (dose-escalation of alemtuzumab, HSCT)
description
Undergo allogeneic peripheral blood stem cell transplantation
name
peripheral blood stem cell transplantation
other Names
PBPC transplantation
PBSC transplantation
peripheral blood progenitor cell transplantation
transplantation, peripheral blood stem cell
type
PROCEDURE
arm Group Labels
Treatment (dose-escalation of alemtuzumab, HSCT)
description
Given PO
name
mycophenolate mofetil
other Names
Cellcept
MMF
type
DRUG
arm Group Labels
Treatment (dose-escalation of alemtuzumab, HSCT)
description
Given IV or PO
name
cyclosporine
other Names
ciclosporin
cyclosporin
cyclosporin A
CYSP
Sandimmune
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 60
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Percentage patients with Day 100 transplant related mortality.
measure
Evaluate the Risk of Transplant Related Mortality.
time Frame
100 days after transplant
description
Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma with bullous formation and often with desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
measure
Evaluate the Risk of Occurrence of Acute and Chronic GVHD
time Frame
1 year after transplant
description
Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as \> 95% donor CD3+ T cells.
measure
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.
time Frame
100 days after transplant

secondary Outcomes

description
Percentage patients who experienced infections within 100 days post-transplant.
measure
Evaluate the Risk/Incidence of Infections
time Frame
100 days after transplant
description
Percentage patients who relapsed/progressed within 1 year post-transplant.
measure
Evaluate the Risk for Disease Progression and Relapse
time Frame
1 year after transplant

Full study description

brief Summary: This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood 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. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.
detailed Description: PRIMARY OBJECTIVES: I. To determine whether stable allogeneic engraftment from related and unrelated human leukocyte antigen (HLA)-mismatched stem cell donors can be safely established using a non-myeloablative conditioning regimen plus escalating doses of the anti-CD52 monoclonal antibody (mAb) Campath (alemtuzumab) in patients with hematologic malignancies. SECONDARY OBJECTIVES: I. Evaluate the risk of occurrence of acute and chronic graft-vs-host disease (GVHD). II. Evaluate the risk/incidence of infections. III. Determine whether engraftment can be maintained with a single dose fludarabine, donor lymphocyte infusion (DLI) and continued MMF/CSP. IV. Evaluate the risk for disease progression and relapse. OUTLINE: This is a dose-escalation study of alemtuzumab. CONDITIONING REGIMEN: Patients receive alemtuzumab intravenously (IV) over 2 hours on days -8 to -5 and fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT): Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or orally (PO) twice daily (BID) on days -3 to 180 with taper to day 365 and MMF PO thrice daily (TID) on days 0-100 with taper to day 156. After completion of study treatment, patients are followed up periodically.

Source references

references

citation
Nakamae H, Storer BE, Storb R, Storek J, Chauncey TR, Pulsipher MA, Petersen FB, Wade JC, Maris MB, Bruno B, Panse J, Petersdorf E, Woolfrey A, Maloney DG, Sandmaier BM. Low-dose total body irradiation and fludarabine conditioning for HLA class I-mismatched donor stem cell transplantation and immunologic recovery in patients with hematologic malignancies: a multicenter trial. Biol Blood Marrow Transplant. 2010 Mar;16(3):384-94. doi: 10.1016/j.bbmt.2009.11.004. Epub 2009 Nov 10.
pmid
19900571
type
RESULT

Source notices and limitations

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8b9a346048372591e3ee0de631ceead25528dc1d384a69971d454af93b26921d
source json pointer
/studies/29/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
d5b05d48912b1359ded646fe089af7312a8725c5c5905dc03223fa6877a47226
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Hairy+Cell+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice