Clinical trial · Interventional
High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas
- 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 chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying high-dose chemotherapy given together with peripheral blood stem cell transplant in treating patients with intestinal T-cell lymphoma.
Conditions
Conditions (2)
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 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| biopsy | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival at 1 year
Secondary outcomes (1)
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly confirmed diagnosis of intestinal T-cell lymphoma/ enteropathy-type T-cell lymphoma according to the following WHO classifications: * Usual phenotype CD3-, CD7-positive; CD5-, CD4-, CD8-negative; or CD30-positive * Complete surgical resection allowed PATIENT CHARACTERISTICS: * Unsupported neutrophils ≥ 1,500/mm\^3 unless attributed to lymphomatous bone marrow infiltration * Unsupported platelets ≥ 100,000/mm\^3 unless attributed to lymphomatous bone marrow infiltration * Creatinine clearance ≥ 50 mL/min * Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN * Left ventricular ejection fraction ≥ 50% * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment * Patients with any serious concomitant medical or psychiatric condition that would preclude them tolerating the planned treatment should be entered into the registration study only * No known hepatitis B, hepatitis C, or HIV positivity * No active uncontrolled cardiovascular disease * No abnormal EKG if there is a previous history of cardiac problems * No other severe impairment of cardiac function * No active malignancy within the past 5 years except cervical intraepithelial neoplasia or localized skin cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior diagnostic or emergency surgical procedures allowed * More than 5 years since prior treatment for malignancy * No prior chemotherapy or radiotherapy for treatment of lymphoma
References
Publications (1)
- DERIVEDPhillips EH, Lannon MM, Lopes A, Chadwick H, Jones G, Sieniawski M, Davies A, Wood K, Clifton-Hadley L, Smith P, Lawrie A, Chadwick N, Lennard AL. High-dose chemotherapy and autologous stem cell transplantation in enteropathy-associated and other aggressive T-cell lymphomas: a UK NCRI/Cancer Research UK Phase II Study. Bone Marrow Transplant. 2019 Mar;54(3):465-468. doi: 10.1038/s41409-018-0294-2. Epub 2018 Aug 13. No abstract available. PMID 30104718