Clinical trial · Interventional
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (Vepesid)(TIME) Followed by Autologous Stem Cell Rescue in High Risk 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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by autologous bone marrow transplantation or peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| etoposide | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TIME
- description
- Topotecan, Ifosfamide, Mesna and Etoposide
- interventionNames
- Drug: etoposide
- Drug: ifosfamide
- Drug: topotecan hydrochloride
- Procedure: autologous bone marrow transplantation
- Drug: Mesna
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 3 years
- description
- Progression-free survival as defined as the time from date of enrollment to the time of recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed non-Hodgkin's lymphoma
* No lymphoblastic lymphoma
* Under 55 years of age:
* Intermediate and high grade or aggressive disease that has relapsed and/or failed at least 2 salvage chemotherapy regimens OR
* Failed to achieve complete response after first line induction chemotherapy and failed at least 1 salvage chemotherapy regimen
* Low grade or indolent disease that has relapsed or failed to achieve complete response after first line induction chemotherapy and failed more than 2 salvage chemotherapy regimens
* 55 years of age and over:
* Intermediate and high grade or aggressive disease that has relapsed and/or failed to achieve complete response after first line induction chemotherapy
* Low grade or indolent disease that has relapsed or failed to achieve complete response after first line induction chemotherapy OR
* Histologically confirmed Hodgkin's lymphoma
* Under 55 years of age:
* Received at least 2 prior salvage chemotherapy regimens
* 55 years of age and over:
* Stage III or IV disease that has relapsed or failed to achieve remission after combination induction chemotherapy
* Prior primary radiotherapy allowed if relapse is high risk (e.g., recurrence in radiation field, B symptoms, or liver or bone marrow involvement)
* No active leptomeningeal involvement or severe symptomatic CNS disease
* Prior CSF tumor involvement allowed if asymptomatic and no evidence of disease on lumbar puncture or no tumor involvement on MRI of the brain
* Solid tumors and brain metastases allowed
* No evidence of disease by MRI and physical exam following optimal prior surgery and/or radiotherapy AND
* At least 3 months since prior radiotherapy NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
* 18 to 64
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 mg/dL\*
* SGOT or SGPT no greater than 2.5 times normal\*
* No severe hepatic dysfunction NOTE: \*Unless due to primary malignancy
Renal:
* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No severe cardiac dysfunction
* Ejection fraction at least 50% by MUGA scan
* Essential hypertension controlled by medication allowed
Pulmonary:
* DLCO at least 50% of normal OR
* No symptomatic obstructive or restrictive disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No active infection
* HIV negative
* No insulin dependent diabetes mellitus
* No uncompensated major thyroid or adrenal dysfunction
* No significant skin breakdown from tumor or other disease
* No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Prior doxorubicin or daunorubicin allowed if total dose no greater than 450 mg/m2
* No prior topotecan
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics
Other:
* No concurrent nitroglycerin preparations for angina pectoris
* No concurrent antiarrhythmic drugs for major ventricular arrhythmiasReferences
Publications (0)
Data not yet available