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Randomized Double Cord Blood Transplant Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00067002
First received: August 8, 2003
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

The goal of this clinical research study is to learn if combining cord blood units to make the cells "take" faster in recipients will help to improve the results of cord blood transplants.


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
Drug: Rituxan
Drug: Melphalan
Drug: Thiotepa
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mesna
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Two Unmanipulated Cord Blood units. Rituxan 375 mg/m2 by vein for patients with CD20 + malignancies. Melphalan 140 mg/m2 by vein on Day -8. Thiotepa 5 mg/Kg by vein on Day -7. Fludarabine 40 mg/m2 by vein on Days -6 to -3.
Procedure: Expanded allogeneic cord blood (CB)
Transplantation of Two Unmanipulated Cord Blood Units.
Other Name: double Cord blood transplant.
Drug: Rituxan
375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.
Other Name: Rituximab
Drug: Melphalan
140 mg/m2 by vein on Day -8.
Other Name: Alkeran
Drug: Thiotepa
5 mg/Kg by vein on Day -7.
Drug: Fludarabine
40 mg/m2 by vein on Days -6 to -3.
Other Names:
  • Fludarabine Phosphate
  • Fludara
Experimental: B
One Unmanipulated and One Expanded Cord Blood Unit. Fludarabine 40 mg/m2 by vein on Days -6 to -3. Cyclophosphamide 50 mg/kg by vein on Day -6. Mesna 10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).
Procedure: One Unmanipulated and One Expanded Cord Blood Unit
Transplantation of One Unmanipulated and One Expanded Cord Blood Unit.
Other Name: Expanded Cord Blood Transplant
Drug: Rituxan
375 mg/m2 by vein on Day - 9 for patients with CD20 + malignancies.
Other Name: Rituximab
Drug: Fludarabine
40 mg/m2 by vein on Days -6 to -3.
Other Names:
  • Fludarabine Phosphate
  • Fludara
Drug: Cyclophosphamide
50 mg/kg by vein on Day -6.
Other Names:
  • Cytoxan
  • Neosar
Drug: Mesna
10 mg/kg by vein before the 1st dose of Cyclophosphamide, then 10 mg/kg every 4 hours for four more doses (total of 50 mg/Kg).
Other Name: Mesnex

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067002

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 770030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Simrit Parmar, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00067002     History of Changes
Other Study ID Numbers: ID02-407, CA061508, NCI-2012-01299
Study First Received: August 8, 2003
Last Updated: September 17, 2014
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
Rituxan
Rituximab
Melphalan
Alkeran
Thiotepa
Fludarabine
Fludarabine phosphate
Fludara
Cyclophosphamide
Cytoxan
Neosar
Mesna
Mesnex

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lymphoma
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Bone Marrow Diseases
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Melphalan
Thiotepa
Vidarabine
Alkylating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 20, 2014