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Trial record 59 of 528 for:    stem cell kidney

GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT02360111
Recruitment Status : Terminated (Lack of accrual)
First Posted : February 10, 2015
Results First Posted : November 8, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE February 5, 2015
First Posted Date  ICMJE February 10, 2015
Results First Submitted Date  ICMJE October 1, 2018
Results First Posted Date  ICMJE November 8, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE February 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
# GVHD (Grade II-IV) Chronic GVHD Will be Diagnosed and Graded According to the (NIH Criteria) [ Time Frame: 2 years ]
Chronic GVHD will be diagnosed and graded according to the (NIH criteria) treated with standard or experimental immunosuppressive therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02360111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2015)
  • Disease-free Survival [ Time Frame: 2 years ]
    DFS is defined as the minimum interval of time to relapse/recurrence, to death or to the last follow-up, from the time of transplant
  • Overall Survival [ Time Frame: 2 years ]
    Overall survival is defined as time from transplant to death or last follow-up.
  • # Renal Insufficiency Defined as a Calculated eGFR <60 ml/Min/1.73m2. Those With a eGFR < 30 ml/Min/1.73m2 Will be Considered Ineligible. [ Time Frame: 2 years ]
    Renal insufficiency is defined as a calculated eGFR <60 ml/min/1.73m2. Those with a eGFR < 30 ml/min/1.73m2 will be considered ineligible.
  • The Occurrence of Life-threatening Opportunistic Infections [ Time Frame: 2 years ]
    will be evaluated according to the criteria established by BMT CTN , and will be correlated with the level of immune recovery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant
Official Title  ICMJE A Pilot Trial of GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant
Brief Summary This is a pilot study which will be done in a small number of patients. The purpose of this study is to test the safety and benefit of giving a type of chemotherapy - cyclophosphamide - after the transplant to prevent graft versus host disease (GVHD) in patients with abnormal kidney function. GVHD is one of the most common complications of a stem cell transplant .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Myelodysplastic Syndrome
  • Non-Hodgkin's Lymphoma
Intervention  ICMJE Drug: Cyclophosphamide
Study Arms  ICMJE Experimental: Post Transplant Cyclophosphamide
Melphalan 70 mg/m 2/d will be administered intravenously on d-6 and -5 Fludarabine 25 mg/m 2/d will be administered intravenously on d-6 thru -2 Day -1 will be a day or rest Cyclophosphamide and mesna will be given on d+3 and +4 Siro +/- MMF will be started in those patients who are to receive it on d+5. Neupogen will begin d+7.
Intervention: Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 27, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2015)
24
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: Patients over age 18 who are deemed eligible for transplant by their treating physician.
  • Disease status:

    1. AML in ≥ 1st remission - excluding those in 1st remission with 'good risk' cytogenetic features (i.e. t(8;21), t(15;17), inv 16).
    2. Secondary AML
    3. ALL/LL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL > 2nd remission
    4. CML failing to respond to, progressing on or not tolerating appropriate TKI therapy in first chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.
    5. Non-Hodgkins lymphoma with chemoresponsive disease in any of the following categories:

      1. high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants or transplants requiring the use of calcineurin inhibitors.
      2. any NHL with therapy responsive disease which is considered not curable outside the transplant setting and not eligible/appropriate for autologous transplant or a higher priority protocol.
    6. Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or transfusion dependence, RAEB-1 and RAEB-2 and AML evolved from MDS, who are not eligible for a higher priority protocol.
    7. Chronic myelomonocytic leukemia: CMML-1 and CMML-2, advanced polycythemia vera, and myelofibrosis.

      1. Patients must have a healthy HLA compatible (8/8 molecularly matched related, or unrelated) donor willing to undergo BM harvesting or PBSC apheresis after G-CSF administration. BM will be the preferred graft source.
      2. Patients diagnosed with any form of acute leukemia must have received induction and at least one course of consolidation chemotherapy pretransplant
  • Patients must have a Karnofsky Performance Status > 70%
  • Patients will have a eGFR <60 ml/min/1.73 m2

    1. Patients must have adequate organ function measured by: Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 50% and must improve with exercise.
    2. Hepatic: ALT < 3 x ULN and total serum bilirubin < 1.5 x ULN, unless there is congenital benign hyperbilirubinemia
    3. Renal: eGFR > 30 ml/min/1.73 m2
    4. Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for hemoglobin)
  • Each patient must be willing to participate as a research subject and must sign an informed consent form.
  • Patient must have a fully matched related or unrelated donor willing to donate stem cells.

Exclusion Criteria:

  • Major surgery or irradiation within two weeks.
  • Active CNS or extramedullary malignant disease.
  • Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection
  • Pregnant or lactating women - they are excluded, given the potential teratogenic effects of chemotherapy and agents used in the transplant.
  • Male and female patients of child-bearing potential unwilling to use effective means of contraception
  • HIV or HTLV I/II positive, hepatitis C or chronic active hepatitis B.
  • Patients who have had a previous malignancy unless they are deemed by their treating physicians to be at low risk for recurrence.
  • Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up and research tests.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02360111
Other Study ID Numbers  ICMJE 14-273
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ann Jakubowski, Ph.D., M.D. Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP