Clinical trial · Observational
Allogeneic Hematopoietic Cell Transplantation for Adult Acute Lymphoblastic Leukemia (2015)
A Prospective Study Evaluating the Efficacy of the Allogeneic Hematopoietic Cell Transplantation With Antithymocyte Globulin (ATG)-Based Conditioning of Adult Acute Lymphoblastic Leukemia in First / Second Complete Hematologic Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.
Summary
Brief summary (as posted)
This study is a prospective multicenter observational study to evaluate the feasibility and the efficacy of the conditioning regimens which are modified by the donor differences and the age of recipients among patients who will receive allogeneic hematopoietic stem cell transplantation in their 1st or 2nd hematologic complete remission (CR).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AlloHCT for Old/MSD | Procedure | — | UNRESOLVED |
| AlloHCT for Old/MUD&FMD | Procedure | — | UNRESOLVED |
| AlloHCT for Young/MSD | Procedure | — | UNRESOLVED |
| AlloHCT for Young/MUD&FMD | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Young/MSD
- description
- Patients who are \<55 years old, and will receive alloHCT for Young/MSD
- interventionNames
- Procedure: AlloHCT for Young/MSD
- label
- Young/MUD&FMD
- description
- Patients who are \<55 years old, and will receive alloHCT for Young/MUD\&FMD
- interventionNames
- Procedure: AlloHCT for Young/MUD&FMD
- label
- Old/MSD
- description
- Patients who are \>=55 years old, and will receive alloHCT for Old/MSD
- interventionNames
- Procedure: AlloHCT for Old/MSD
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who has been previously diagnosed as one of the following disease; * Acute lymphoblastic leukemia * Biphenotypic acute leukemia with Philadelphia-positive chromosome or gene translocation * Patients whose disease status is one of the following; * First hematologic complete remission (HCR1) * Second hematologic complete remission (HCR2) * 15 years of age and over. * With a suitable donor (matched sibling, well-matched unrelated, partially-matched unrelated, and haploidentical familial donor) * Adequate cardiac function (EF\>45% via cardiac scan or EchoCG) * European Clinical Oncology Group (ECOG) performance status ≥grade 2 or Karnofsky scale \>60% at the time of screening * All patients give written informed consent according to guidelines at institution's committee on human research. Exclusion Criteria: * Acute lymphoblastic leukemia L3 type (Burkitt leukemia/lymphoma) * Biphenotypic acute leukemia without BCR-ABL1 translocation * Lymphoblastic lymphoma (bone marrow blast count is below 20% of mononuclear cells of bone marrow aspirate) * Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible * Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception * Male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc). * Patients with a diagnosis of prior malignancy (including hematologic malignancies such as acute leukemia, lymphoma, multiple myeloma, and myelodysplastic syndrome, etc) unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
References
Publications (37)
- BACKGROUNDSiegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014 Jan-Feb;64(1):9-29. doi: 10.3322/caac.21208. Epub 2014 Jan 7. PMID 24399786
- BACKGROUNDMa H, Sun H, Sun X. Survival improvement by decade of patients aged 0-14 years with acute lymphoblastic leukemia: a SEER analysis. Sci Rep. 2014 Feb 27;4:4227. doi: 10.1038/srep04227. PMID 24572378
- BACKGROUNDForman SJ, Rowe JM. The myth of the second remission of acute leukemia in the adult. Blood. 2013 Feb 14;121(7):1077-82. doi: 10.1182/blood-2012-08-234492. Epub 2012 Dec 14. PMID 23243288
- BACKGROUNDGoldstone AH, Richards SM, Lazarus HM, Tallman MS, Buck G, Fielding AK, Burnett AK, Chopra R, Wiernik PH, Foroni L, Paietta E, Litzow MR, Marks DI, Durrant J, McMillan A, Franklin IM, Luger S, Ciobanu N, Rowe JM. In adults with standard-risk acute lymphoblastic leukemia, the greatest benefit is achieved from a matched sibling allogeneic transplantation in first complete remission, and an autologous transplantation is less effective than conventional consolidation/maintenance chemotherapy in all patients: final results of the International ALL Trial (MRC UKALL XII/ECOG E2993). Blood. 2008 Feb 15;111(4):1827-33. doi: 10.1182/blood-2007-10-116582. Epub 2007 Nov 29. PMID 18048644
- BACKGROUNDBray RA, Hurley CK, Kamani NR, Woolfrey A, Muller C, Spellman S, Setterholm M, Confer DL. National marrow donor program HLA matching guidelines for unrelated adult donor hematopoietic cell transplants. Biol Blood Marrow Transplant. 2008 Sep;14(9 Suppl):45-53. doi: 10.1016/j.bbmt.2008.06.014. No abstract available. PMID 18721780
- BACKGROUNDLee SJ, Klein J, Haagenson M, Baxter-Lowe LA, Confer DL, Eapen M, Fernandez-Vina M, Flomenberg N, Horowitz M, Hurley CK, Noreen H, Oudshoorn M, Petersdorf E, Setterholm M, Spellman S, Weisdorf D, Williams TM, Anasetti C. High-resolution donor-recipient HLA matching contributes to the success of unrelated donor marrow transplantation. Blood. 2007 Dec 15;110(13):4576-83. doi: 10.1182/blood-2007-06-097386. Epub 2007 Sep 4.