Allo-Allo Tandem Bone Marrow Transplant (BMT)

NCT00984412 | Unknown Phase 1

• 1 other identifier: MYS-07-HMO-CTIL
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Refractory Acute Leukemia

Outcome Measures

Primary Outcomes (2)

• Transplant-related mortality (TRM) of SCT II.

  240d

• Transplant-related toxicity (TRT) of SCT II.

  240d

Secondary Outcomes (10)

• Day of neutrophil engraftment at SCT II

  240d

• Day of platelet engraftment >20x109/L at SCT II

  240d

• Day of platelet engraftment >50x109/L at SCT II

  240d

• Acute GVHD occurrence ≥ 2 following SCT II

  100d

• Time to acute GVHD following SCT II

  100d

Study Arms (1)

AATT

EXPERIMENTAL

Procedure: Allogeneic hematopoietic stem-cell-transplantation

Interventions

Allogeneic hematopoietic stem-cell-transplantation PROCEDURE

2 allogeneic BMTs 6 weeks apart

AATT

Eligibility Criteria

• Age: 3 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• A donor willing and capable of donating peripheral blood stem cells and preferably also bone marrow cells, and lymphocytes if indicated.
• Each patient / patient's guardian must sign written informed consent.
• 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.

You may not qualify if:

• In complete or very good partial remission.
• Beyond 2nd relapse.
• Received \> 2 lines of salvage therapy.
• Active CNS involvement of the leukemia
• Active life-threatening infection.
• Overt untreated infection.
• HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
• 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).
• Previous autologous or allogeneic stem cell transplantation.
• Inability to comply with study requirements.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Related Publications (2)

• Tournilhac O, Altmann B, Friedrichs B, Bouabdallah K, Leclerc M, Cartron G, Turlure P, Reimer P, Wagner-Drouet E, Sanhes L, Houot R, Roussel M, Kroschinsky F, Dreger P, Viardot A, de Leval L, Rosenwald A, Gaulard P, Wulf G, Villate A, Latiere C, Elmaagacli A, Glass B, Poeschel V, Damaj G, Sibon D, Durot E, Bilger K, Banos A, Haenel M, Dreyling M, Keller U, Tiab M, Drenou B, Cornillon J, Nguyen S, Robin M, Nickelsen M, Trumper L, Lenz G, Ziepert M, Schmitz N; French Lymphoma Study Association (LYSA), the Societe Francophone de greffe de moelle et Therapie Cellulaire (SFGM-TC), and the German Lymphoma Alliance (GLA). Long-Term Follow-Up of the Prospective Randomized AATT Study (Autologous or Allogeneic Transplantation in Patients With Peripheral T-Cell Lymphoma). J Clin Oncol. 2024 Nov 10;42(32):3788-3794. doi: 10.1200/JCO.24.00554. Epub 2024 Sep 13.

  PMID: 39270145 DERIVED

• Schmitz N, Truemper L, Bouabdallah K, Ziepert M, Leclerc M, Cartron G, Jaccard A, Reimer P, Wagner E, Wilhelm M, Sanhes L, Lamy T, de Leval L, Rosenwald A, Roussel M, Kroschinsky F, Lindemann W, Dreger P, Viardot A, Milpied N, Gisselbrecht C, Wulf G, Gyan E, Gaulard P, Bay JO, Glass B, Poeschel V, Damaj G, Sibon D, Delmer A, Bilger K, Banos A, Haenel M, Dreyling M, Metzner B, Keller U, Braulke F, Friedrichs B, Nickelsen M, Altmann B, Tournilhac O. A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL. Blood. 2021 May 13;137(19):2646-2656. doi: 10.1182/blood.2020008825.

  PMID: 33512419 DERIVED

Central Study Contacts

Michael Y Shapira, MD

CONTACT

972-2-6778351; shapiram@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof shapira

Study Record Dates

• First Submitted: September 6, 2009
• First Posted: September 25, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

IL (1)