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Allo-Allo Tandem Bone Marrow Transplant (BMT) (AATT)

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ClinicalTrials.gov Identifier: NCT00984412
Recruitment Status : Recruiting
First Posted : September 25, 2009
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
SHAPIRA MICHAEL, Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE September 6, 2009
First Posted Date  ICMJE September 25, 2009
Last Update Posted Date February 19, 2016
Study Start Date  ICMJE November 2009
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
  • Transplant-related mortality (TRM) of SCT II. [ Time Frame: 240d ]
  • Transplant-related toxicity (TRT) of SCT II. [ Time Frame: 240d ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00984412 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
  • Day of neutrophil engraftment at SCT II [ Time Frame: 240d ]
  • Day of platelet engraftment >20x109/L at SCT II [ Time Frame: 240d ]
  • Day of platelet engraftment >50x109/L at SCT II [ Time Frame: 240d ]
  • Acute GVHD occurrence ≥ 2 following SCT II [ Time Frame: 100d ]
  • Time to acute GVHD following SCT II [ Time Frame: 100d ]
  • GVHD grade following SCT II [ Time Frame: 240d ]
  • Overall survival at 180 days from SCT II [ Time Frame: 180d ]
  • Disease free survival at 180 days SCT II [ Time Frame: 180d ]
  • Infections incidence [ Time Frame: 240d ]
  • Immune reconstitution [ Time Frame: 240d ]
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 Allo-Allo Tandem Bone Marrow Transplant (BMT)
Official Title  ICMJE Allo-allo Tandem Matched Stem Cell Transplantation (AATT) for the Treatment of Patients With Refractory Acute Leukemia; a Feasibility Phase I/II Study
Brief Summary Refractory acute leukemia (AL) occurs in a significant percentage of the AL patients and presents a therapeutic challenge. Allogeneic stem cell transplantation (allo-SCT) is the only curative option for these patients. Although many of the patients with refractory AL that undergo myeloablative SCT initially achieve complete remission, most relapse later on, and the long-term disease free survival is poor. In order to achieve better leukemic control, most transplant centers employ post transplant early withdrawal of the anti-GVHD immunosuppression; hence exposing the patients to high risk of GVHD associated morbidity and mortality. This study will try to address this common scenario, namely early and late relapse. The investigators will try to attain better leukemic control by re-inducing the patients, 6 weeks after the 1st transplant with further myeloablative treatment (busulfex and thiotepa) followed by allogeneic stem cell support (transplant II).
Detailed Description

The effects of feasibility oExperimental design and methods f allo-allo tandem matched stem cell transplantation (AATT) in patients with refractory leukemia will be evaluated in a clinical setting. The current study is limited only for patients with refractory disease that received and failed up to 2 lines of salvage therapy, in good performance status and younger than 50 years old. Only patients that will achieve complete remission after transplant I, will have no major organ dysfunction and with acceptable performance status, will be treated with transplant II. Close monitoring with strict stopping rules including in case of excess transplant related morality, acute or chronic GVHD or graft failure will be employed.

Treatment schedule:

15 patients (divided into 2 cohorts, see below) with matched family member or unrelated donor will be included in single arm open phase I/II trial.

Conditioning protocol:

All patients will be prepared by the same sequential conditioning protocols:

Transplant I: Cy-TBI followed by Transplant II: Busulfan-thiotepa.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Acute Leukemia
Intervention  ICMJE Procedure: Allogeneic hematopoietic stem-cell-transplantation
2 allogeneic BMTs 6 weeks apart
Study Arms  ICMJE Experimental: AATT
Intervention: Procedure: Allogeneic hematopoietic stem-cell-transplantation
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2009)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient age 3-50 years old with refractory acute leukemia (primary refractory or refractory relapse I or II) unresponsive to up to 2 salvage lines with a matched donor (related or unrelated, matched defined as 8/8 HLA matching).
  2. A donor willing and capable of donating peripheral blood stem cells and preferably also bone marrow cells, and lymphocytes if indicated.
  3. Each patient / patient's guardian must sign written informed consent.
  4. Patients must have an ECOG PS ≤ 1; Creatinine <1.5 mg/dl; Ejection fraction >45%; DLCO >70% of predicted; Serum bilirubin <2 mg/dl; elevated GPT or GOT < 2 x normal values before transplant I.

Exclusion Criteria:

  1. Not fulfilling any of the inclusion criteria.
  2. In complete or very good partial remission.
  3. Beyond 2nd relapse.
  4. Received > 2 lines of salvage therapy.
  5. Active CNS involvement of the leukemia
  6. Active life-threatening infection.
  7. Overt untreated infection.
  8. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
  9. Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia, HCV, evidence of bone marrow disease, unable to donate bone marrow or peripheral blood due to concurrent medical condition).
  10. Previous autologous or allogeneic stem cell transplantation.
  11. Inability to comply with study requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Y Shapira, MD 972-2-6778351 shapiram@hadassah.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00984412
Other Study ID Numbers  ICMJE MYS-07-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SHAPIRA MICHAEL, Hadassah Medical Organization
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hadassah Medical Organization
Verification Date February 2016

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