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NCT00571662 · REGISTRY CONDITION SEARCH

Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant

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
2023-10-24

This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT).

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

Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting

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outcome · POSTED

Toxicity for the Combination of Pentostatin and Low Dose Total Body Irradiation (TBI)

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outcome · POSTED

Incidence of Acute and Chronic Graft-versus-host Disease

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outcome · POSTED

Responses to Therapy

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outcome · POSTED

Kinetics of Immunologic Reconstitution

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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: Age 19-75 years 1. Patients who relapse after autologous stem cell transplantation. 2. Patients who are candidates for an autologous or conventional allogeneic stem cell transplantation from a disease standpoint but who do not qualify functionally (from the point of view of organ function, or performance status) for a myeloablative protocol. 3. Any patient, where in the opinion of the primary treating oncologist, nonmyleoablative therapy would be the treatment option in the best patients interest providing the patient fits all other eligibility criteria for this protocol. Identification of a matched related or unrelated stem cell donor Diseases: Acute myelogenous leukemia first complete remission with high-risk cytogenetics\>second complete remission minimal residual disease (\<10% blasts\*). Acute lymphocytic leukemia first complete remission with high-risk cytogenetics \>second complete remission minimal residual disease (\<10% blasts\*). Chronic myelogenous leukemia first chronic phase, accelerated phase (\<10% blasts\*)blast phase with minimal residual disease (\<10% blasts\*)second chronic phase. Chronic lymphocytic leukemia recurrence after the front line regimen (related donor transplant), chemorefractory disease (unrelated donor transplant),T-CLL in partial remission or any minimal residual disease. Myelodysplastic syndromes refractory anemia with or without ringed sideroblasts,RAEB, RAEB-T, and CMML (\< than 10% blasts\*). \*both in peripheral blood and bone marrow Multiple myeloma - after receiving at least one regimen of prior chemotherapy Non-Hodgkin's Lymphomas: Small Lympho(plasma)cytic Lymphoma (B-SLL, B-LPL): recurrence after a front line regimen (related donor transplant), or chemorefractory disease (related or unrelated donor transplant). Follicular Low-Grade Lymphoma, Marginal Zone Lymphomas (splenic, nodal, or extranodal/MALT type): chemorefractory disease or \> 2 prior regimens. Mantle Cell Lymphoma: first complete or partial remission, refractory disease, or failed prior ASCT. Diffuse Large B-cell Lymphoma, Follicular Large cell Lymphoma, Peripheral T-cell Lymphoma, Anaplastic Large Cell Lymphoma: refractory disease, or failed prior ASCT. Burkitt or Acute Lymphoblastic Lymphomas: high-risk disease in remission, chemosensitive persistent or recurrent disease. Cutaneous T-cell Lymphomas: (Mycosis Fungoides, Sezary Syndrome): chemorefractory disease of \> 2 prior regimens Hodgkins Disease: refractory or persistent disease and not candidate for ASCT, or failed prior ASCT. Peripheral T-cell Lymphoma Exclusion Criteria: * Age \> 75 years and \< 19 years * progressive disease within 8 weeks of prior therapy or within 12 weeks after prior autologous stem cell transplantation * Active CNS malignancy (patients with known positive CSF cytology or parenchymal lesions visible by CT or MRI) * Fertile men or women unwilling to use appropriate contraceptive techniques during and for 12 months following treatment * Females who are pregnant * Patients who are HIV seropositive * Active uncontrolled infection or immediate life-threatening condition at the time of enrollment * Significant Organ dysfunction: 1. Calculated Creatinine Clearance \<55ml/min 2. cardiac ejection fraction \<40%, NYHA class II or greater cardiac disease. 3. DLCO \< 40% , FEV1/FVC ratio \<50% predicted, or receiving supplementary continuous oxygen 4. total bilirubin \> 2x upper limit of normal (unless due to Gilberts disease or malignancy), ALT and AST 4x the upper limit of normal * Karnofsky score \<60% * Patients with uncontrolled medical illnesses (e.g., uncontrolled systemic hypertension, diabetes) Donor Inclusion Criteria: * HLA genotypically matched relative * siblings or first-degree relatives matched at HLA-A, B, or DR loci (6 antigen match) are acceptable donors * HLA matched unrelated volunteer donor * unrelated donor matched at HLA-A, B, or DR loci (6 antigen match) are acceptable donors * One antigen mismatch related or unrelated donor will also be acceptable, molecular typing needs to be used at each H LA-A, B, or DR loci in case of mismatched unrelated donor. Donor Exclusion Criteria: * Identical twin * Pregnancy * HIV positive * Serious Allergy to G-CSF * Current serious systemic illness * Failure to meet the UNMC or NMDP criteria for donors
healthy Volunteers
false
maximum Age
75 Years
minimum Age
19 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Pentostatin to be administered intravenously on days - 10, -9, and -8 at a dose of 4mg/m2/day
    intervention Names
    1. Drug: Pentostatin
    2. Radiation: Total-body irradiation (TBI)
    3. Drug: Cyclosporine A (CsA)
    4. Drug: Mycophenolate Mofetil (MMF)
    5. Drug: G-CSF
    label
    Cohort I
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort I
    description
    4 mg/m\^2 intravenous(IV)once a day(QD)x3days (days -10, -9, -8)
    name
    Pentostatin
    other Names
    1. Nipent
    type
    DRUG
  2. arm Group Labels
    1. Cohort I
    description
    TBI will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. TBI will be given on day -1.
    name
    Total-body irradiation (TBI)
    type
    RADIATION
  3. arm Group Labels
    1. Cohort I
    description
    CsA will be given at 2.0 mg/kg intravenous (IV) Q 12hrs on days -1,0,and+1 (total 6 doses) then converted to oral at 2 mg/kg by mouth (PO) twice a day (BID) until day+80, then tapered 10% per week over approximately 3 months if no GVHD for related donor transplants. For unrelated CsA will be given at same dose and schedule until day+100 then tapered by 10% per week if no GVHD
    name
    Cyclosporine A (CsA)
    other Names
    1. Neoral
    type
    DRUG
  4. arm Group Labels
    1. Cohort I
    description
    MMF 15 mg/kg by mouth twice a day (PO BID) will be given from day 0-27 then stopped without tapering for related donor transplants. For unrelated donor transplants MMF will be given at same dose until day+40 then tapered over 2months. in absence of GVHD. Doses will be rounded to nearest 250 mg.
    name
    Mycophenolate Mofetil (MMF)
    type
    DRUG
  5. arm Group Labels
    1. Cohort I
    description
    10 mcg/kg/day subcutaneously for at least 4 consecutive days.
    name
    G-CSF
    other Names
    1. Leukine
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
76
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    the efficacy of the regimen as determined by engraftment rate and establishment of donor hematopoietic chimerism at day +28 and day +70.
    measure
    Percent of Participants With Chimerism: Full Donor Chimerism Defined as >95% Donor CD3+ Cell in Blood as Assessed by DNA Fingerprinting
    time Frame
    days +28 and +70
  2. measure
    Toxicity for the Combination of Pentostatin and Low Dose Total Body Irradiation (TBI)
    time Frame
    Conditioning regimen to count recovery (D + 28 post transplant)
secondary Outcomes
  1. description
    Incidence of acute and chronic graft-versus-host disease. Acute GVHD usually occurs during the first three months following transplant. Chronic GVHD usually develops after the third month post-transplant.
    measure
    Incidence of Acute and Chronic Graft-versus-host Disease
    time Frame
    twice weekly until day 100 up to 1 year post transplant
  2. description
    event-free and overall survival at 12 months
    measure
    Responses to Therapy
    time Frame
    every 6 mo. up to 2 years
  3. description
    Rate of return of immune cells after allogeneic transplantation
    measure
    Kinetics of Immunologic Reconstitution
    time Frame
    at day 100 post transplantation
Full study description
brief Summary
This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT).
detailed Description
This is a pilot study which began with a plan to enroll 50 patients (20 related and 30 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with Pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT). Patients with persistent or progressive malignancy after transplantation will be treated with GM-CSF (cytokine therapy) to assess its toxicity and potential therapeutic efficacy. Patients with persistent or progressive disease who fail or do not qualify for the cytokine therapy portion of the study will become candidates for donor leukocyte infusions. The purpose of this protocol remains a pilot study which is now regarded as a phase II trial with a plan to enroll 40 ADDITIONAL patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a modified version of the original preparative regimen of Pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT). Patients who fail will become candidates for donor-leukocyte infusion (DLI). Primary Objectives 1. To determine the safety of treating hematological malignancies by establishing donor hematopoietic chimerism using pentostatin and low-dose total body irradiation followed by allogeneic peripheral blood stem cell transplantation. 2. To determine the immunomodulatory effects of pentostatin as part of the conditioning regimen for allogeneic peripheral blood stem cell transplantation. Secondary Objectives 1. To determine the incidence of infections after using a minimally myelosuppressive conditioning regimen. 2. To determine the kinetics of hematological and immunological reconstitution after allotransplantation with a minimally myelosuppressive conditioning regimen. 3. To determine the incidence of chronic GVHD after using allogeneic peripheral blood stem cell transplantation with a minimally myelosuppressive preparative regimen. 4. To evaluate the role of the preparative regimen and donor source (related versus unrelated) on inflammatory cytokine profiles. 5. To evaluate blood and where possible, biopsy specimens for a recently identified nuclear protein (molecular weight 44/46) in mononuclear cells obtained from study subjects. Interventions, evaluation, and follow up will include: Pentostatin 4 mg/m\^2/d intravenously once a day x 3 days will be administered with 1000 cc NS hydration before and after pentostatin ten days prior to stem cell infusion (days -10, -9, and -8). Total-body irradiation (TBI): TBI 2.0 Gy will be given on day -1. Antiemetics will be given as needed. Patients will receive one liter normal saline over 2 hours pre TBI. A bone marrow biopsy and aspiration with cytogenetics and flow cytometry will be performed on Day +28, Day +70 and 6, 12, 18 and 24 months following the transplant to monitor hematologic recovery. DNA fingerprinting will also be conducted at the same time at 3, 4, 5, 6, 12, 18, and 24 months to determine chimerism.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice