Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia

Herbert Irving Comprehensive Cancer Center

Status and phase: Unknown; Phase 2

Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Childhood Langerhans Cell Histiocytosis; Lymphoma; Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

Treatments: Procedure: umbilical cord blood transplantation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00008164

CPMC-CAMP-021

CPMC-IRB-7934

CDR0000068384

NCI-G00-1899

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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