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T-Cell-Depleted Allogeneic Stem Cell Transplantation After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2007

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00080925
  Purpose

RATIONALE: Donor peripheral stem cell transplantation may be able to replace bone marrow and immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them and giving cyclosporine may prevent this from happening.

PURPOSE: This phase I trial is studying the side effects of T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning (chemotherapy) in treating patients with hematologic malignancies.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Drug: cyclophosphamide
Drug: cyclosporine
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: filgrastim
Drug: fludarabine phosphate
Drug: prednisone
Drug: rituximab
Drug: therapeutic allogeneic lymphocytes
Drug: vincristine sulfate
Procedure: graft-versus-tumor induction therapy
Procedure: peripheral blood stem cell transplantation
Phase I

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Lymphoma    Multiple Myeloma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Filgrastim    Cytarabine    Cytarabine hydrochloride    Etoposide    Prednisone    Vincristine sulfate    Vincristine    Fludarabine    Fludarabine monophosphate    Rituximab    Cyclosporin    Cyclosporine    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   20
Study Start Date:   February 2004

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following hematologic malignancies:

    • Acute myeloid leukemia (AML), meeting 1 of the following criteria:

      • In first complete remission (CR1), meeting 1 of the following criteria:

        • Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR), defined as 1 of the following:

          • Complex karyotype [≥ 3 abnormalities]
          • inv(3) or t(3;3)
          • t(6;9)
          • t(6;11)
          • Monosomy 7
          • Trisomy 8, alone or with an abnormality other than t(8;21), t(9;11), inv(16), or t(16;16)
          • t(11;19) (q23;p13.1)
        • Failed to achieve CR after primary induction chemotherapy
        • Secondary AML
      • In second or subsequent remission (CR2 or greater)
    • Acute lymphoblastic leukemia, meeting 1 of the following criteria:

      • In CR1, meeting 1 of the following criteria:

        • Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, FISH, or PCR, defined as the following:

          • Translocations involving 11q23, t(9;22), or bcr-abl rearrangement
        • Failed to achieve CR after primary induction chemotherapy
      • In CR2, if CR1 was < 12 months
      • In CR3 or greater
    • Myelodysplastic syndromes (MDS)

      • INT-2 or high-risk by International Prognostic Scoring System
      • No MDS with Fanconi anemia
    • Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:

      • Accelerated phase with treatment failure after imatinib mesylate
      • Blast phase
    • Myeloproliferative disorders, meeting 1 of the following criteria:

      • Agnogenic myeloid metaplasia with adverse-risk features, meeting at least 2 of the following criteria:

        • Hemoglobin < 10 g/dL or > 10g/dL if transfusion-dependent
        • WBC < 4,000/mm^3 OR > 30,000/mm^3 OR requires cytoreductive therapy to maintain WBC < 30,000/mm^3
        • Abnormal cytogenetics, including +8, 12p-
      • Polycythemia vera or essential thrombocythemia in transformation to secondary AML
    • Myelodysplastic/myeloproliferative disease

      • Chronic myelomonocytic leukemia
    • Hodgkin's lymphoma or non-Hodgkin's lymphoma

      • Refractory lymphoma with progressive disease during combination chemotherapy
      • Relapse after OR ineligible for autologous stem cell transplantation (SCT)
    • Chronic lymphocytic leukemia

      • Treatment failure* after fludarabine, chlorambucil, and at least 1 other salvage regimen
    • Prolymphocytic leukemia (PLL), meeting 1 of the following criteria:

      • T-PLL

        • Treatment failure* after alemtuzumab and at least 1 other regimen
      • B-PLL

        • Treatment failure* after fludarabine and at least 1 other salvage regimen
    • Multiple myeloma, meeting 1 of the following criteria:

      • Relapse after autologous SCT
      • Plasma cell leukemia
      • Adverse cytogenetics, defined as 1 of the following:

        • del(13q) = 11q translocation NOTE: *Treatment failure is defined as relapse within 6 months OR failure to achieve remission
  • Less than 10% blasts in bone marrow and no circulating blasts in peripheral blood for the following diagnoses:

    • Primary or secondary leukemia
    • Refractory anemia with excess blasts
    • CML
    • Other eligible diagnosis in transformation to acute leukemia
  • Expected survival of approximately 1 year or less with conventional therapy
  • No active CNS involvement by malignancy*

    • Prior CNS involvement with no current evidence of CNS malignancy allowed NOTE: *Active CNS malignancy is defined by lymphoma: tumor mass on CT scan or leptomeningeal disease OR leukemia: blasts present on cerebrospinal fluid cytospin
  • Availability of a donor who is a sibling, parent, or offspring who shares 1 full haplotype (HLA-A, -B, or -DR)

    • Recipient and donor must have at least a 2-antigen disparity in either the host-versus-graft or graft-versus-host direction
    • Parent or offspring donor who is mismatched for a single HLA antigen (i.e., 5/6 HLA) is allowed
    • No sibling donor who is 6/6 HLA-matched OR mismatched for a single HLA antigen (i.e., 5/6 HLA)
    • No unrelated donor identified in a prior or current National Marrow Donor Program registry search

PATIENT CHARACTERISTICS:

Age

  • 18 to 55

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • At least 3 months

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,000/mm^3*
  • Platelet count ≥ 20,0000/mm^3* (without transfusion) NOTE: *Lower values may be accepted at the discretion of the principal investigator or study chairperson if due to bone marrow involvement by malignancy

Hepatic

  • ALT and AST ≤ 2.5 times upper limit of normal (ULN)*
  • Bilirubin ≤ 2.5 times ULN*
  • Unconjugated hyperbilirubinemia consistent with Gilbert's syndrome allowed
  • No chronic active hepatitis B infection

    • Hepatitis B core antibody positive allowed provided patient is surface antigen negative and has no evidence of active infection
  • No hepatitis C viral infection

    • Seronegative for anti-hepatitis C antibody and detectable hepatitis C viral RNA by reverse transcriptase-polymerase chain reaction assay NOTE: *Higher levels may be accepted at the discretion of the principle investigator or study chairperson if such elevations are due to liver involvement by malignancy

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • LVEF ≥ 45%

Pulmonary

  • DLCO ≥ 50% of expected value (corrected for blood hemoglobin level and alveolar volume)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after study participation
  • HIV negative
  • No active infection not responding to antimicrobial therapy
  • No psychiatric disorder that would preclude study compliance or informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 2 weeks since prior monoclonal antibody therapy

Chemotherapy

  • See Disease Characteristics
  • At least 2 weeks since prior systemic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • At least 1 week since prior tyrosine kinase inhibitors imatinib mesylate and dasatinib
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080925

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office     Recruiting
      Bethesda, Maryland, United States, 20892-1182
      Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Michael R. Bishop, MD     NCI - Center for Cancer Research-Medical Oncology    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 
Featured trial article  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000357432, NCI-04-C-0116
First Received:   April 7, 2004
Last Updated:   November 13, 2008
ClinicalTrials.gov Identifier:   NCT00080925
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
prolymphocytic leukemia  
accelerated phase chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
relapsing chronic myelogenous leukemia  
refractory chronic lymphocytic leukemia  
de novo myelodysplastic syndromes  
myelodysplastic/myeloproliferative disease, unclassifiable  
previously treated myelodysplastic syndromes  
secondary myelodysplastic syndromes  
secondary acute myeloid leukemia  
recurrent adult Hodgkin lymphoma  
refractory anemia with excess blasts  
refractory multiple myeloma  
chronic idiopathic myelofibrosis  
recurrent adult diffuse large cell lymphoma  
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
chronic myelomonocytic leukemia
polycythemia vera
essential thrombocythemia
stage II multiple myeloma

Study placed in the following topic categories:
Polycythemia
Prednisone
Cyclosporine
Chronic myelogenous leukemia
Chronic myelomonocytic leukemia
Refractory anemia
Miconazole
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Cyclosporins
Lymphoma, large-cell, immunoblastic
Preleukemia
Leukemia, Prolymphocytic
Anemia, Refractory
Hemorrhagic Disorders
Multiple myeloma
Hemorrhagic thrombocythemia
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Acute myeloid leukemia, adult
Etoposide
Hodgkin Disease
Essential thrombocytosis
Chronic lymphocytic leukemia
Myelodysplastic syndromes
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Rituximab

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antibiotics, Antineoplastic
Hormones
Neoplasms by Site
Pathologic Processes
Syndrome
Therapeutic Uses
Antifungal Agents
Cardiovascular Diseases
Alkylating Agents
Dermatologic Agents
Disease
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Glucocorticoids
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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