Clinical trial · Interventional
Combination Chemotherapy Followed By Stem Cell Transplant in Treating Young Patients With Progressive or Relapsed Anaplastic Large Cell Lymphoma
Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Giving combination chemotherapy and total-body irradiation before a peripheral stem cell transplant that uses the patient's or a donor's stem cells, helps stop both the growth of cancer cells and the patient's immune system from rejecting the stem cells. When the stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy and total-body irradiation followed by a stem cell transplant may be an effective treatment for anaplastic large cell lymphoma. PURPOSE: This clinical trial is studying how well combination chemotherapy followed by stem cell transplant works in treating young patients with progressive or relapsed anaplastic large cell lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (23)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| carmustine | Drug | Carmustine | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event-free survival as measured by the Kaplan-Meier method
Secondary outcomes (5)
- measure
- Proportion of patients who are treated on protocol among all patients who meet the inclusion criteria
- measure
- Overall survival
- measure
- Acute and long term toxicity
- measure
- Rate of acute and chronic graft-vs-host disease in patients with allogeneic stem cell transplantation
- measure
- Treatment related mortality
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed anaplastic large cell lymphoma (ALCL)
* Progressive disease OR first relapse
* No second or subsequent relapse of ALCL
* Slides available for national central pathology review
* Availability of 1 of the following (for allogeneic stem cell transplantation only):
* HLA-identical matched sibling donor
* 10/10 HLA-matched nonsibling donor (related or unrelated)
* 9/10 HLA-matched nonsibling donor (1-antigen-mismatched related or unrelated donor)
* \< 9/10 HLA-mismatched donor (related or unrelated)
* Stem cells may be obtained from unmanipulated bone marrow or peripheral blood stem cells after filgrastim (G-CSF) stimulation
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Adequate hepatic, renal, and cardiac function
* No HIV infection or AIDS
* No severe immunodeficiency
* No other prior malignancy
* No pre-existing disease or condition prohibiting study treatment
PRIOR CONCURRENT THERAPY:
* At least 2 months since prior chemotherapy or radiotherapy
* No significant pretreatment for first relapse
* No prior organ transplantation
* No concurrent participation in another clinical trialReferences
Publications (1)
- DERIVEDKnorr F, Brugieres L, Pillon M, Zimmermann M, Ruf S, Attarbaschi A, Mellgren K, Burke GAA, Uyttebroeck A, Wrobel G, Beishuizen A, Aladjidi N, Reiter A, Woessmann W; European Inter-Group for Childhood Non-Hodgkin Lymphoma. Stem Cell Transplantation and Vinblastine Monotherapy for Relapsed Pediatric Anaplastic Large Cell Lymphoma: Results of the International, Prospective ALCL-Relapse Trial. J Clin Oncol. 2020 Dec 1;38(34):3999-4009. doi: 10.1200/JCO.20.00157. Epub 2020 Jul 30. PMID 32730187