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Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Aplastic Anemia

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00053989
First Posted: February 6, 2003
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
  Purpose

RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood 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 system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy before or after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well chemotherapy followed by donor peripheral stem cell transplant works in treating patients with hematologic cancer or aplastic anemia.


Condition Intervention Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Biological: anti-thymocyte globulin Biological: graft-versus-tumor induction therapy Biological: sargramostim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate Drug: methylprednisolone Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Aplastic Anemia

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Safety [ Time Frame: Weekly while on study ]
  • Toxicity [ Time Frame: Weekly while on study ]
  • Clinical response [ Time Frame: Weekly until day +100 ]
  • Overall outcome [ Time Frame: Yearly until progression ]
  • Incidence of graft-vs-tumor effect, graft-vs-host disease, and chimerism [ Time Frame: Day 30-40, day 60-70 and day 100-120 ]

Enrollment: 41
Actual Study Start Date: January 29, 2002
Estimated Study Completion Date: May 1, 2018
Estimated Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: anti-thymocyte globulin
    iv
    Biological: graft-versus-tumor induction therapy
    iv
    Biological: sargramostim
    iv
    Biological: therapeutic allogeneic lymphocytes
    iv
    Drug: cyclophosphamide
    injection
    Drug: fludarabine phosphate
    iv
    Other Name: FLUDARA
    Drug: methylprednisolone
    oral
    Drug: mycophenolate mofetil
    oral
    Drug: tacrolimus
    oral
    Procedure: allogeneic bone marrow transplantation
    iv
    Procedure: peripheral blood stem cell transplantation
    iv
    Procedure: umbilical cord blood transplantation
    iv
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of aplastic anemia

    • Severe disease
    • Failed at least 1 course of standard immunosuppressive regimen with cyclosporine and anti-thymocyte globulin OR
  • Histologically confirmed hematologic malignancy including the following:

    • Acute leukemia

      • Any of the following types:

        • Acute myeloid leukemia (AML) with antecedent myelodysplastic syndromes
        • Secondary AML
        • AML with high-risk cytogenetic abnormalities
        • Acute lymphoblastic leukemia with high-risk cytogenetic abnormalities
      • Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen OR
      • In first remission at high risk of relapse
    • Chronic myelogenous leukemia

      • Chronic phase meeting at least 1 of the following criteria:

        • Failed imatinib mesylate
        • Failed interferon after at least 6 months of treatment with minimum of 21 million units of interferon per week
        • Unable to tolerate interferon
      • Accelerated phase (blasts less than 20%)
    • Myeloproliferative and myelodysplastic syndromes

      • Myelofibrosis (after splenectomy)
      • Refractory anemia
      • Refractory anemia with excess blasts
      • Chronic myelomonocytic leukemia
    • Lymphoproliferative disease

      • Chronic lymphocytic leukemia

        • Symptomatic disease after first-line chemotherapy
      • Low-grade non-Hodgkin's lymphoma (recurrent or persistent)

        • Symptomatic disease after first-line chemotherapy
      • Multiple myeloma

        • Progressive disease after autologous stem cell transplantation
      • Waldenstrom's macroglobulinemia

        • Failed 1 standard regimen
    • Non-Hodgkin's lymphoma meeting the following criteria:

      • Intermediate or high grade
      • Controlled and chemosensitive disease
      • First remission lymphoblastic or small non-cleaved cell lymphoma at high risk of relapse
    • Hodgkin's lymphoma

      • Relapsed and chemosensitive disease
  • Not eligible for standard myeloablative allogeneic stem cell transplantation
  • Availability of any of the following donor types:

    • Related donor matched at 5 or 6 HLA antigens (A, B, DR)
    • Unrelated donor fully matched by molecular analysis at A, B, DRB1, and DQB1 loci

      • Single antigen mismatch at C allowed
    • Cord blood that is 4, 5, or 6 match with recipient HLA antigens (A, B, DR) NOTE: No syngeneic donors permitted
  • No uncontrolled CNS disease (for hematologic malignancies) 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:

Age

  • 5 to 75 (if related donor transplantation)
  • 5 to 60 (if unrelated donor transplantation)

Performance status

  • Karnofsky > 50%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin less than 3 times normal
  • Alkaline phosphatase less than 3 times normal
  • AST/ALT less than 3 times normal
  • No Child's class B or C liver failure

Renal

  • Creatinine clearance greater than 40 mL/min

Cardiovascular

  • Cardiac ventricular ejection fraction at least 35% by MUGA
  • No cardiovascular disease

Pulmonary

  • DLCO at least 40% of predicted, corrected for hemoglobin and/or alveolar ventilation

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV antibody negative
  • No uncontrolled diabetes mellitus
  • No active serious infection
  • No other disease that would preclude study therapy
  • No other concurrent malignancy except non-melanoma skin cancer
  • No concurrent serious psychiatric illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 6 months since prior autologous bone marrow transplantation (BMT)
  • At least 12 months since prior allogeneic BMT

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • At least 4 weeks since prior surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053989


Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Philip L. McCarthy, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00053989     History of Changes
Other Study ID Numbers: CDR0000269673
RP01-05
First Submitted: February 5, 2003
First Posted: February 6, 2003
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Roswell Park Cancer Institute:
accelerated phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
primary myelofibrosis
de novo myelodysplastic syndromes
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
refractory anemia with excess blasts
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Waldenstrom macroglobulinemia
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
noncontiguous stage II adult Burkitt lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
adult acute myeloid leukemia in remission
secondary acute myeloid leukemia
recurrent childhood acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
childhood acute lymphoblastic leukemia in remission
adult acute lymphoblastic leukemia in remission
noncontiguous stage II adult lymphoblastic lymphoma
refractory multiple myeloma
refractory anemia
refractory chronic lymphocytic leukemia
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
grade 1 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Anemia
Myelodysplastic Syndromes
Preleukemia
Anemia, Aplastic
Plasmacytoma
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Cyclophosphamide