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Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

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. Identifier: NCT00008216
Recruitment Status : Terminated (Poor enrollment)
First Posted : January 27, 2003
Last Update Posted : June 6, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Savage, Columbia University

Brief Summary:

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 or disease Intervention/treatment
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

Detailed Description:


  • 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation
Study Start Date : July 1996
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Group/Cohort Intervention/treatment
alloSCT group
Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).
Procedure: Peripheral Blood Stem Cell Transplantation

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

  2. Time to engraftment [ Time Frame: 6 months ]
    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 :
  1. Clinical response [ Time Frame: 6 months ]
    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).

  2. Survival rate [ Time Frame: 6 months ]
  3. Number of participants with Graft-versus-host disease [ Time Frame: 6 months ]
  4. Time to treatment failure and relapse [ Time Frame: 6 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing allogeneic blood or marrow stem cell transplantation (alloSCT).


  • 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



  • 65 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified

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 identifier (NCT number): NCT00008216

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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
National Cancer Institute (NCI)
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Principal Investigator: David G. Savage, MD Herbert Irving Comprehensive Cancer Center
Additional Information:

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Responsible Party: David Savage, Professor of Medicine, Columbia University Identifier: NCT00008216    
Other Study ID Numbers: AAAA5571
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014
Keywords provided by David Savage, 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:
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Multiple Myeloma
Neoplasms, Plasma Cell
Histiocytosis, Langerhans-Cell
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Lung Diseases, Interstitial
Lung Diseases