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NCT03346096: TEAM
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) for AutoSCT in Lymphoma
Phase 2 trial testing Thiotepa in Malignant Lymphoma in 50 participants. Completed in 30 June 2024.
30 June 2024
Quick facts
| Lead sponsor | Sheba Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 9 October 2018 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Thiotepa — full drug profile →
Conditions studied
- Malignant Lymphoma — all drugs for Malignant Lymphoma →
Sponsor
Sheba Medical Center
Who can join
Adults 18 to 70, any sex, with Malignant Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study is designed to explore whether the introduction of Thiotepa, to the pre autologous stem-cell transplantation (ASCT) conditioning will reduce toxicity and thus improve outcome following transplantation in up to 24 patients with malignant lymphoma including both non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma ( HL) improving toxicity profile , reducing side effects while potentially improving the antitumor response. Specifically,we speculate that using the novel Thiotepa based TEAM consisted of THIOTEPA 5mg/kg on days -7-6, etoposide 200 mg/m2 , Cytosar (ARA-C) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2 on day -1, pre transplantation conditioning regimen may allow transplantation with lower transplant related toxicity and thus improve outcome in this setting. Toward this aim the impact on toxicity profile ,engraftment and disease control will be assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03346096
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Thiotepa
Trials testing the same drug.
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- NCT07441967 — The Safety and Efficacy of the Regimen of Thiotepa + Fludarabine +Granulocyte Colony-Stimulating Factor+ Cytarabine + Bu · Phase 2 · not yet recruiting
- NCT07276737 — Preconditioning With a Combination of Thiotepa, Cyclophosphamide, and Busulfan for Allogeneic Hematopoietic Stem Cell Tr · Phase 2 · not yet recruiting
- NCT06942039 — Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation · EARLY_PHASE1 · recruiting
- NCT06807606 — Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Rela · Phase 2 · recruiting
Other recruiting trials for Malignant Lymphoma
Currently open trials in the same condition.
- NCT06475820 — Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Baricitinib at Children and Yo · Phase 2, PHASE3 · active not recruiting
- NCT05515029 — Preventing of GVHD With Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Calcineurin Inhibitor at Patie · Phase 3 · active not recruiting
Other Sheba Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03346096 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sheba Medical Center
- Last refreshed: 9 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03346096.
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