Clinical trial · Interventional
Phase III Study Treatment of CLL B and C
A Multicentric Phase III Study in Patients With CLL B and C < 60 Years Not Treated: 6 Montly CHOP + 6 CHOP Every 3 Months Versus 3 Montly CHOP + Intensification and Autograft
- 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)
GOELAMS LLC98 is a prospective randomized trial comparing in previously untreated B and C Binet stages B-CLL and on an intent to treat basis two strategies. Conventional chemotherapy consisted of six monthly courses of CHOP, followed by 6 CHOP courses every other 3 months in case of response. Experimental arm consisted of high dose therapy with autologous CD34+ purified progenitor cell support, used as consolidation of Complete Remission or Very Good Partial Response obtained after 3 monthly courses of CHOP, followed by 3 to 6 monthly-courses of fludarabine in case of insufficient response.
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 |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stem cells autograft | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A
- description
- ¨Chemotherapy by 12 courses of CHOP
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- ¨Chemotherapy by 3 courses of CHOP, intensification and autograft
- interventionNames
- Procedure: Stem cells autograft
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- Overal survival
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * CLL with Lymphocitis \> 15.10 9/L * B-CLL stage B or C * Patients \> 18 years old and \< 60 years old * No previous treatment of CLL * ECOG performance status \< 2 * Good cardiac function * Patient's written informed consent Exclusion Criteria: * B-CLL stage A * Age \> 60 years old * previous treatment of CLL * ECOG performance status \> 2 * Cardiac or pneumo Insufficency * hepatic or renal Insufficency * Seropositivity HIV * Previous other malignancy * Fertile male and female patients who cannot or do not wish to use an effective method of contraception * Any coexisting medical or psychological condition that would preclude participation to the required study procedures * NOt signed Patient's informed consent
References
Publications (0)
Data not yet available