Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Savage, Columbia University
ClinicalTrials.gov Identifier:
NCT00008216
First received: January 6, 2001
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem 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.

PURPOSE: This phase II trial is studying the effectiveness of donor peripheral blood stem cell transplant in treating patients with hematologic cancer.


Condition Intervention Phase
Adult Langerhans Cell Histiocytosis
Childhood Langerhans Cell Histiocytosis
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Procedure: Peripheral Blood Stem Cell Transplantation
Phase 2

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Lymphoma, Small Cleaved-cell, Diffuse Acute Lymphoblastic Leukemia Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Multiple Myeloma Chronic Myeloproliferative Disorders Hodgkin Lymphoma Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic/myeloproliferative Disease Acute Myeloid Leukemia, Adult Follicular Lymphoma Hodgkin Lymphoma, Childhood B-cell Lymphomas Juvenile Myelomonocytic Leukemia Burkitt Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Lymphoblastic Lymphoma Small Non-cleaved Cell Lymphoma Anaplastic Large Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Chronic Myelomonocytic Leukemia Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia, Childhood Mantle Cell Lymphoma Cutaneous T-cell Lymphoma Hand-Schuller-Christian Disease Langerhans Cell Histiocytosis Leukemia, T-cell, Chronic Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Mycosis Fungoides Sezary Syndrome Anaplastic Plasmacytoma
U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of irreversible severe (grade 3) or life-threatening or lethal (grade 4-5) organ toxicities.

  • Time to engraftment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Days from infusion of stem cells to recovery of PMN > 500/ul for two consecutive determinations, transfusion independence for platelets (>20,000/ul) and RBCs (Hct > 25%). The bone marrow function is considered durable if reconstitution persists for at least 6 months.


Secondary Outcome Measures:
  • Clinical response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of participants with a partial response (residual though reduced evidence of active disease) and/or complete response (disappearance of all measurable disease, signs, symptoms, and hematologic or biochemical changes related to the disease, for >3 months).

  • Survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of participants with Graft-versus-host disease [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Time to treatment failure and relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Time from day 1 of chemoradiotherapy to transplant-related death or disease relapse.


Biospecimen Retention:   Samples Without DNA

Standard bloodwork that would be required for transplantation patients


Enrollment: 48
Study Start Date: July 1996
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
alloSCT group
Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).
Procedure: Peripheral Blood Stem Cell Transplantation

Detailed Description:

OBJECTIVES:

  • Determine the efficacy and safety of allogeneic peripheral blood stem cell transplantation in achieving engraftment in patients with hematologic malignancy.
  • Determine the hematopoietic recovery, incidence of chemoradiotherapeutic toxicity, relapse, graft-versus-host disease, and survival of patients treated with this regimen.

OUTLINE: Patients receive a preparative chemoradiotherapeutic regimen and graft-versus-host disease prophylaxis prior to transplantation. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.

Patients are followed every 1-2 weeks for 6 months and at 9, 12, 24, and 36 months.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following:

    • Chronic myelogenous leukemia

      • Philadelphia chromosome-positive OR
      • Molecular evidence of bcr/abl gene rearrangement
    • Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses, myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia

      • Confirmed by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
    • Multiple myeloma
    • Hereditary immunodeficiency disorders

      • Confirmed by immunologic determination
    • Sickle cell anemia or beta-thalassemia

      • Confirmed by hemoglobin electrophoresis
    • Storage disorders (e.g., Gaucher's disease, Hurler's disease, or metachromatic leukodystrophy)

      • Confirmed by metabolic testing
    • Other non-malignant conditions
  • Eligible for allogeneic peripheral blood stem cell or bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

  • 65 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008216

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: David G. Savage, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: David Savage, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00008216     History of Changes
Other Study ID Numbers: AAAA5571, CPMC-IRB-AAAA5571, CPMC-CAMP-016, NCI-G00-1891
Study First Received: January 6, 2001
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
stage IV adult Hodgkin lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
childhood Langerhans cell histiocytosis
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
untreated childhood acute lymphoblastic leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
chronic myelogenous leukemia, BCR-ABL1 positive

Additional relevant MeSH terms:
Neoplasms
Histiocytosis
Histiocytosis, Langerhans-Cell
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Lymphoma, Large-Cell, Immunoblastic
Myelodysplastic-Myeloproliferative Diseases
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 14, 2014