Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer

Lymphoma Clinical Trial

Official title:

The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00008216
• Other study ID #: AAAA5571
• Secondary ID: CPMC-IRB-AAAA557
• Status: Terminated
• Phase: Phase 2
• First received: January 6, 2001
• Last updated: June 5, 2014
• Start date: July 1996
• Est. completion date: January 2009

Study information

• Verified date: June 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult Langerhans Cell Histiocytosis
• Childhood Langerhans Cell Histiocytosis
• Histiocytosis
• Histiocytosis, Langerhans-Cell
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia

Intervention

Procedure:
• Peripheral Blood Stem Cell Transplantation

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity	Number of irreversible severe (grade 3) or life-threatening or lethal (grade 4-5) organ toxicities.	6 months	Yes
Primary	Time to engraftment	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.	6 months	No
Secondary	Clinical response	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).	6 months	No
Secondary	Survival rate		6 months	No
Secondary	Number of participants with Graft-versus-host disease		6 months	Yes
Secondary	Time to treatment failure and relapse	Time from day 1 of chemoradiotherapy to transplant-related death or disease relapse.	6 months	No