Overview

This trial is active, not recruiting.

Conditions childhood langerhans cell histiocytosis, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms
Treatment umbilical cord blood transplantation
Phase phase 2
Sponsor Herbert Irving Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date January 1997
Trial size 30 participants
Trial identifier NCT00008164, CDR0000068384, CPMC-CAMP-021, CPMC-IRB-7934, NCI-G00-1899

Summary

RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental blood transplantation in treating patients who have hematologic cancer or aplastic anemia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Measure
Response rate
time frame:
Toxicity
time frame:
Survival
time frame:
Incidence of graft-versus-host disease
time frame:

Eligibility Criteria

Male or female participants up to 60 years old.

DISEASE CHARACTERISTICS: - Diagnosis of chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder - Eligible for allogeneic bone marrow transplantation, but lacking a donor - Available donor umbilical cord blood that is mismatched on no more than 2 HLA loci - HIV negative - Hepatitis B surface antigen and hepatitis C negative PATIENT CHARACTERISTICS: Age: - Under physiologic 60 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 2 times normal - No severe hepatic disease - Hepatitis B surface antigen and hepatitis C negative Renal: - Creatinine less than 2 times normal Other: - HIV negative - Not pregnant or nursing - No other serious medical or psychiatric illness that would preclude study compliance - No serious infection PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified

Additional Information

Official title Transplantation Using Umbilical Cord And Placental Blood
Description OBJECTIVES: - Determine the response rate of patients with chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder treated with allogeneic umbilical cord and placental blood transplantation. - Determine the toxicity of this regimen in these patients. - Determine survival in these patients treated with this regimen. - Determine the incidence of graft-versus-host disease in these patients treated with this regimen. OUTLINE: Patients receive a standard preparative regimen for their disease. Following the preparative regimen patients undergo umbilical cord blood stem cell transplantation on day 0. Patients are followed every 1-2 weeks for 6 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 4-5 years.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).