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Refractory Acute LeukemiaPhase 1/2AATTNCT00984412

Allo-Allo Tandem Bone Marrow Transplant (BMT)

A Phase 1/2 study testing Allogeneic hematopoietic stem-cell-transplantation in people with Refractory Acute Leukemia, run by Hadassah Medical Organization at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 50 years
Conditions the study is for
Refractory Acute Leukemia
What is being tested?
Allogeneic hematopoietic stem-cell-transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteIsrael
Study dates
Nov 2009to Nov 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • Not fulfilling any of the inclusion criteria.
  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Michael Y Shapira, MD contact

972-2-6778351

shapiram@hadassah.org.il

Israel1 site, 1 recruiting

  • Hadassah Medical Organization

    Jerusalem

    Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il

    Hadas Lamberg, PhD, 00972 2 6777572, Ihadas@hadassah.org.il

    Recruiting

Other trials in Israel

About this study

Official title: Allo-allo Tandem Matched Stem Cell Transplantation (AATT) for the Treatment of Patients With Refractory Acute Leukemia; a Feasibility Phase I/II Study

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).

Read the 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.

Being tested
Allogeneic hematopoietic stem-cell-transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic hematopoietic stem-cell-transplantationProcedure or surgery

    2 allogeneic BMTs 6 weeks apart

Study groups in NCT00984412
Study groupRoleWhat they receive
AATTExperimentalNot described
Receives: Procedure: Allogeneic hematopoietic stem-cell-transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 240d

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

    Measured: 240d

Secondary outcomes (10)

  1. Day of neutrophil engraftment at SCT II

    Measured: 240d

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

    Measured: 240d

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

    Measured: 240d

  4. Acute GVHD occurrence ≥ 2 following SCT II

    Measured: 100d

  5. Time to acute GVHD following SCT II

    Measured: 100d

  6. GVHD grade following SCT II

    Measured: 240d

  7. Overall survival at 180 days from SCT II

    Measured: 180d

  8. Disease free survival at 180 days SCT II

    Measured: 180d

  9. Infections incidence

    Measured: 240d

  10. Immune reconstitution

    Measured: 240d

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionApr 2020 (estimated)
  4. Study completionNov 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00984412
Sponsor's protocol ID
MYS-07-HMO-CTIL
Acronym
AATT
Status last verified
Feb 2016
First submitted
6 Sep 2009
Last updated
19 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39270145

  • 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.

    PubMed 33512419

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Allogeneic hematopoietic stem-cell-transplantation in people with Refractory Acute Leukemia, run by Hadassah Medical Organization at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael Y Shapira, MD (972-2-6778351, shapiram@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transplant-related mortality (TRM) of SCT II. (time frame: 240d). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00984412, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.

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