Clinical trial · Interventional
Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma
Risk-Adapted High Dose Chemoradiotherapy and Autologous Stem Cell Transplantation for Patients With Relapsed and Primary Refractory Hodgkin's Lymphoma
- 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: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow from the patient, may allow more chemotherapy to be given so that more cancer cells are killed. Giving combination chemotherapy together with radiation therapy before an autologous stem cell transplant may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation therapy work in treating patients who are undergoing an autologous stem cell transplant for relapsed or refractory Hodgkin's 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cytoreductive chemotherapy group 1
- description
- Patients receive ICE comprising ifosfamide IV and carboplatin IV once on day 2 and etoposide IV over 1 hour once daily on days 1-3. Patients then receive ifosfamide IV twice on day 15, carboplatin IV once on day 17 and etoposide IV over 1 hour twice daily on days 15-17.
- interventionNames
- Drug: carboplatin
- Drug: etoposide
- Drug: ifosfamide
- type
- EXPERIMENTAL
- label
- Cytoreductive chemotherapy group 2
- description
- Patients receive ifosfamide IV twice on days 1 and 17, carboplatin IV once on days 3 and 19, and etoposide IV over 1 hour twice daily on days 1-3 and 17-19.
- interventionNames
- Drug: carboplatin
- Drug: etoposide
- Drug: ifosfamide
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of Classical Hodgkin's Lymphoma. Lymphocyte predominant histology will be excluded. * Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site * Failure of doxorubicin or nitrogen mustard containing front-line therapy * 18F-fluorodeoxyglucose-PET scan demonstrating PET avid disease * Cardiac ejection fraction of greater than 45%, measured since last chemotherapy. * Adjusted diffusing capacity of greater than 50% on pulmonary function testing, measured since last chemotherapy * Serum creatinine \< than or = to 1.5 mg/dl; if creatinine \>1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be \>60 ml/minute. * ANC\>1000/μl and Platelets\>50,000/μl * Total bilirubin \< than or = to 2.0 mg/dl in the absence of a history of Gilbert's disease. * Females of childbearing age must be on an acceptable form of birth control. * Age between 18 and 72 * HIV I and II negative. * Patients or their guardians must be capable of providing informed consent. Exclusion Criteria: Histology for Lymphocyte predominant subtype Hodgkin's Lymphoma * Prior treatment with carboplatin, cisplatin, ifosfamide, gemcitabine, or vinorelbine * Hepatitis B surface antigen positive. * Known pregnancy or breast-feeding. * Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, will preclude administering chemotherapy safely. * History of any malignancy for which the disease-free interval is \<5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix
References
Publications (2)
- DERIVEDDriessen J, Zwezerijnen GJC, Schoder H, Kersten MJ, Moskowitz AJ, Moskowitz CH, Eertink JJ, Heymans MW, Boellaard R, Zijlstra JM. Prognostic model using 18F-FDG PET radiomics predicts progression-free survival in relapsed/refractory Hodgkin lymphoma. Blood Adv. 2023 Nov 14;7(21):6732-6743. doi: 10.1182/bloodadvances.2023010404. PMID 37722357
- DERIVEDMoskowitz CH, Matasar MJ, Zelenetz AD, Nimer SD, Gerecitano J, Hamlin P, Horwitz S, Moskowitz AJ, Noy A, Palomba L, Perales MA, Portlock C, Straus D, Maragulia JC, Schoder H, Yahalom J. Normalization of pre-ASCT, FDG-PET imaging with second-line, non-cross-resistant, chemotherapy programs improves event-free survival in patients with Hodgkin lymphoma. Blood. 2012 Feb 16;119(7):1665-70. doi: 10.1182/blood-2011-10-388058. Epub 2011 Dec 19. PMID 22184409