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Randomized Double Cord Blood Transplant Study
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2009
First Received: August 8, 2003   Last Updated: September 17, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00067002
  Purpose

Primary objective:

In a prospective, phase II randomized study, to evaluate the transplantation of two unmanipulated cord blood units ("double cord blood" transplant) versus one unmanipulated and one expanded cord blood unit ("expanded cord blood transplant") in patients with hematologic malignancies following high-dose or nonmyeloablative therapy:

  • To evaluate the rate, extent, and durability of hematopoietic reconstitution

Secondary objectives:

  • To evaluate the rate and severity of graft versus host disease
  • To evaluate the rates of infectious complications
  • To evaluate the rates of disease-free and overall survival

Condition Intervention Phase
Leukemia, Lymphocytic, Acute
Leukemia, Myelocytic, Acute
Leukemia, Myeloid, Chronic
Lymphoma, Non-Hodgkin
Procedure: Expanded allogeneic cord blood (CB)
Procedure: One Unmanipulated and One Expanded Cord Blood Unit
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Trial of Unmanipulated Versus Expanded Cord Blood

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time-to-engraftment [ Time Frame: Evaluation and blood tests twice weekly during first 100 days. ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: April 2003
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Two Unmanipulated Cord Blood units
Procedure: Expanded allogeneic cord blood (CB)
Transplantation of Two Unmanipulated Cord Blood Units
B: Experimental
One Unmanipulated and One Expanded Cord Blood Unit
Procedure: One Unmanipulated and One Expanded Cord Blood Unit
Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Disease-Specific Eligibility Requirements: Patients must have one of the following hematologic malignancies: 1. Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS) 2. Acute Lymphoblastic Leukemia (ALL) 3. Chronic Myelogenous Leukemia (CML) 4. Non-Hodgkin's Lymphoma (NHL) 5. Hodgkin's Disease (HD) 6. Chronic Lymphocytic Leukemia (CLL) 7. Chronic eosinophilic leukemia or Philadelphia chromosome negative CML.
  2. Greater than 1 month old and <=60 years old for full myeloablative therapy.
  3. Patients must have two CB units available which are matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. Each cord must contain at least 1E7 total nucleated cells/Kg recipient body weight in the pre-thawed fraction.
  4. Patient must be willing to undergo bone marrow harvest or PBPC collection for use in case of engraftment failure. If the patient is unable or fails to successfully undergo the collection, a family member must be identified to donate hematopoietic stem cells for haploidentical transplant in case of engraftment failure. If autologous hematopoietic stem cells cannot be procured due to marrow contamination by malignancy, or due to harvest failure, and a haploidentical relative is not available or not willing to donate, two cord blood units can be used as the back-up graft.
  5. Continuation to Criteria # 4: These units will be identified prior to enrollment in this study.
  6. Regimen 1 (Myeloablative mel/thiotepa/fludarabine): 1.Patients with ALL, HD, NHL, AML, MDS, CML, CLL and Chronic eosinophilic leukemia who are candidates for full myeloablative therapy. 2.Performance score of at least 60% by Karnofsky (age >= 12 years), or Lansky Play-Performance Scale (age <12 years). 3.Age >=1 month <=60 years (high-dose).
  7. Continuation to Criteria # 6: 4.Adequate major organ system function as demonstrated by:a. Left ventricular ejection function of at least 40%. b.Pulmonary function test demonstrating a diffusion capacity of at least 50%. predicted (high-dose). c.Creatinine < 1.6 mg/dL. d.SGPT/bilirubin <= to 2.0 x normal (high-dose).
  8. Eligibility for Regimen 2 (Non-myeloablative Cy-Flu-TBI): 1. Patients with ALL, AML, MDS, CML, NHL, CLL, Chronic eosinophilic leukemia and HD who are not candidates for full myeloablative therapy. All patients who received a prior autologous transplant are eligible. 2. Performance score of at least 60% by Karnofsky or PS < 3 (ECOG) (age >= 12 years), or Lansky Play-Performance Scale (age <12 years) 3. Age >= 1 month <=80 years
  9. Continuation to Criteria # 8: 4. Left ventricular ejection function of at least 30%; 5. Pulmonary function test demonstrating a diffusion capacity of at least 40% predicted; 6. Creatinine < 3.0 mg/dL; 7. SGPT <= to 4.0 x normal.
  10. Regimen 3 (Myeloablative VP16-TBI): 1. Patients with ALL who are candidates for myeloablative therapy, and require a TBI-containing regimen. 2. Performance score of at least 60% by Karnofsky or PS < 2 (ECOG) (age >= 12 years), or Lansky Play-Performance Scale (age <12 years). 3. Age >= 1 month <=50 years. 4. Organ function requirements: a. Left ventricular ejection function of at least 50%. b. Pulmonary function test demonstrating a diffusion capacity of at least 50% predicted. c. Creatinine < 1.6 mg/dL. d. SGPT <= 2.0 x normal.

Exclusion Criteria:

  1. HIV positive.
  2. Pregnancy.
  3. Serious medical Condition.
  4. Patients with signs & symptoms leading to positive lumbar puncture (malignant cells in the CSF) or to documented metastatic parenchymal disease are ineligible for this study.
  5. Availability of appropriate, willing, HLA-matched related donor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067002

Contacts
Contact: Marcos De Lima, MD 713-792-8750

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 770030
Contact: Brenda Muriera, RN     713-745-1957     bmuriera@mdanderson.org    
Contact: Patricia A Williams, RN     713 794-1634        
Principal Investigator: Marcos De Lima, MD            
Sub-Investigator: Elizabeth Shpall, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Marcos De Lima, MD U.T. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T. M.D. Anderson Cancer Center ( Marcos de Lima, MD/Assoc. Professor )
Study ID Numbers: ID02-407
Study First Received: August 8, 2003
Last Updated: September 17, 2009
ClinicalTrials.gov Identifier: NCT00067002     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
ALL
Leukemia, Lymphocytic, Acute
AML
Leukemia, Myelocytic, Acute
CML
Leukemia, Myeloid, Chronic
NHL
Lymphoma, Non-Hodgkin
double cord blood transplant
expanded cord blood transplant

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009