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NCT00547196Completed

AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders

Allogeneic Stem Cell Transplantation for Patients With Hematological Malignancies Using Multiple Unrelated Cord Blood Units

Source: ClinicalTrials.gov · Last updated 14 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

RATIONALE: Giving chemotherapy with or without total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well four different chemotherapy regimens given with or without total-body irradiation before umbilical cord blood transplant work in treating patients with relapsed or refractory hematologic cancer.

Status (registry)
Completed
Study type
Interventional
Enrollment
10 (actual)
First submitted
19 Oct 2007
Start date
16 Aug 2005
Primary completion date
11 Nov 2009
Lead sponsor
City of Hope Medical Center
NCT number
NCT00547196

What you commit to

  • Study type: Interventional
  • Participants enrolled: 10
  • From 16 Aug 2005 to the primary completion date, 11 Nov 2009
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed hematological or lymphatic malignancy, including any of the following:
    • Acute myeloid leukemia
    • Relapsed or primary refractory disease with \< 10% blasts on peripheral blood smear
    • In first remission with poor risk factors and molecular prognosis \[i.e., AML with -5, -7, t(6;9), tri8, -11\] (preparative regimen 3 or 4)
    • Acute lymphocytic leukemia
    • In second complete remission or higher OR in first remission with poor risk factors, including any of the following (preparative regimen 1 or 2):
    • BCR/ABL by fluorescence in situ hybridization (FISH) or reverse transcriptase-polymerase chain reaction
    • t(9;22)(q34;q11) detected by cytogenetics
    • Chromosomes \< 44 by cytogenetics
    • DNA index \< 0.81 by flow cytometry
    • Any rearrangement of chromosome 11 that results in disruption of MLL gene (11q23) by cytogenetics and SER
    • In first remission with poor risk factors and molecular prognosis \[ALL with Philadelphia chromosome-positive t(9;22), t(4;22), (q34;q11)\] (preparative regimen 3 or 4)
    • Chronic myelogenous leukemia
    • In accelerated phase or greater (preparative regimen 1 or 2)
    • In accelerated or second chronic phase (preparative regimen 3 or 4)
    • Myelodysplastic syndromes
    • With deletion of chromosome 7 or short arm of chromosome 5 (preparative regimen 1 or 2)
    • In high and high-intermediate risk categories (preparative regimen 3 or 4)
    • Non-Hodgkin lymphoma in relapse with marrow involvement
    • Refractory chronic lymphocytic leukemia
  • Patients deemed ineligible for conventional high-dose chemotherapy programs (i.e., regimens 1 or 2) due to any of the following concurrent medical conditions may be eligible for regimens 3 or 4 at the discretion of the treating physician and principal investigator (preparative regimen 3 or 4):
    • LVEF \< 50% and \> 40%
    • FEV1, FVC, or DLCO \< 50%
    • Bilirubin \> 3 mg/dL
    • Creatinine \> 2 mg/dL
  • Two partially HLA-matched umbilical cord blood (UCB) units available
    • HLA-matched minimally at 4 of 6 HLA-A, HLA-B, and -DRB1 loci with the patient
    • DRB1 matched by high resolution DNA typing
    • HLA-A and HLA-B matched by low resolution at the "serological match" level
    • Two pooled units with a nucleated cell number \> 2.5 x 10\^7/kg
  • No available HLA-identical sibling or 1 antigen-mismatched related donor
  • No available HLA-matched unrelated bone marrow donor
    • PATIENT CHARACTERISTICS:
  • See Disease Characteristics
  • Karnofsky performance status (PS) 60-100% OR Lansky PS 60-100% OR Zubrod PS 0-1
  • Physiological age 60 or less (at any chronological age)
  • Weight \> 50 kg
  • Creatinine normal for age OR creatinine clearance by 24-hour urine collection or glomerular filtration rate \> 60 mL/min
  • Bilirubin ≤ 1.5 mg/dL
  • LVEF ≥ 50%
  • DLCO ≥ 60% of predicted
  • No HIV-1 infection
  • No active uncontrolled infection
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
    • PRIOR CONCURRENT THERAPY:
  • Recovered from prior intensive chemotherapy

Age in the registry: 0 years to 120 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
City of Hope Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
Banner Good Samaritan Medical Center
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.