NCT00619645 · REGISTRY CONDITION SEARCH

Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers

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: 2018-01-10

Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops 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 cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.

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 Patients With Day 100 Transplant-related Mortality

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outcome · POSTED

Number of Patients Without Progression After Day 100 Transplant

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outcome · POSTED

Number of Patients Alive 24 Months Post Day 100 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: DISEASE CHARACTERISTICS: * Diagnosed with any of the following: * Acute myeloid leukemia (AML), meeting 1 of the following criteria: * Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required) * In first complete remission (CR1) with poor-risk cytogenetics, antecedent hematological disease (i.e., myelodysplasia), or treatment-related leukemia * Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria: * Recurrent disease in remission, defined as morphological remission with bone marrow aspirate/biopsy showing ≤ 5% within 4 weeks before the start of study treatment (cytogenetic or molecular remission is not required) * CR1 with Philadelphia chromosome or poor-risk cytogenetics * Chronic myelogenous leukemia (CML), meeting the following criteria: * First or second chronic phase * Must be documented disease progression after imatinib mesylate therapy OR documented lack of cytogenetic response 6 months post-imatinib mesylate initiation OR imatinib mesylate intolerance * Chronic lymphocytic leukemia (CLL), meeting the following criteria: * Recurrent disease after fludarabine-based therapy * Must have chemosensitive disease at the time of relapse, defined as greater than 50% reduction of WBC and lymphadenopathy * Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease\*), or transformed NHL, meeting 1 of the following criteria: * Received prior autologous transplantation and cytoreductive therapy at the time of relapse to achieve complete remission (CR) or CR/unconfirmed (CRu) as defined by the International Workshop * Relapsed disease that required more than 2 salvage regimens to achieve CR or CRu * Recurrent multiple myeloma, meeting the following criteria: * Must have received prior autologous transplantation and demonstrate chemosensitivity at the time of relapse, defined as greater than 50% reduction of M-component or plasma-cell marrow infiltration * Myelodysplastic syndrome * Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria: * Must be transfusion-dependent and have an IPSS score ≥ 1.5, based on WHO criteria * No RAEB II or del(5q) * No uncontrolled CNS metastases * 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor (both patient and donor) available PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 50% * Serum creatinine ≤ 2 mg/dL * Not pregnant * Fertile patients must use effective contraception * 50 years of age or older * Patients 18-50 years of age are eligible if meeting 1 of the following criteria: * Have a preexisting medical condition * Received prior therapy (i.e., autologous transplantation) and are considered to be too high risk for conventional myeloablative transplantation * Must be willing to accept or comprehend irreversible sterility as a side effect of therapy * No uncontrolled active infection * No psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible * Cardiac ejection fraction ≥ 30% * Corrected pulmonary-diffusing capacity ≥ 35% * No serologic evidence of infection with HIV * No decompensated liver disease with serum bilirubin \> 2.0 mg/dL PRIOR CONCURRENT THERAPY: * See Disease Characteristics
healthy Volunteers: false
maximum Age: 120 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy
intervention Names
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
label
RIST for Heme malignancies
type
OTHER

interventions

arm Group Labels
RIST for Heme malignancies
name
busulfan
type
DRUG
arm Group Labels
RIST for Heme malignancies
name
cyclosporine
type
DRUG
arm Group Labels
RIST for Heme malignancies
name
fludarabine phosphate
type
DRUG
arm Group Labels
RIST for Heme malignancies
name
mycophenolate mofetil
type
DRUG
arm Group Labels
RIST for Heme malignancies
name
allogeneic hematopoietic stem cell transplantation
type
PROCEDURE
arm Group Labels
RIST for Heme malignancies
name
peripheral blood stem cell transplantation
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 8
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant.
measure
Number of Patients With Day 100 Transplant-related Mortality
time Frame
24 months after day 100 transplant

secondary Outcomes

description
All patients will be followed for progression for 24 months after their day 100 transplant.
measure
Number of Patients Without Progression After Day 100 Transplant
time Frame
24 months after day 100 transplant
description
Patients will be followed for survival for 24 months post day 100 transplant.
measure
Number of Patients Alive 24 Months Post Day 100 Transplant
time Frame
24 months post day 100 transplant

Full study description

brief Summary: Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops 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 cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.
detailed Description: OUTLINE: * Conditioning regimen: Patients receive busulfan IV over 3 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. * Allogeneic peripheral blood stem cell transplant (PBSC): Patients undergo allogeneic PBSC on day 0. * Immunosuppressive therapy/graft-versus-host disease (GVHD) prophylaxis: Patients achieve100% donor T-cell chimerism on day 30 without disease recurrence, and cyclosporine A (CSA) IV continuously over 24 hours or orally every 12 hours on days -1 to 60 followed by a taper until day 100 and oral mycophenolate mofetil (MMF) once every 12 hours on days 1-40, in the absence of ≥ grade 2 GVHD. Patients with recurrent disease or \< 100% donor T-cell chimerism (on day 30) undergo a 12-day CSA and MMF taper followed by escalating doses of previously collected donor leukocyte infusion every 4 weeks until 100% donor T-cell chimerism or disease regression, in the absence of ≥ grade 2 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