Clinical trial · Interventional
G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients
A Randomized Study Comparing Chemotherapy Followed by G-CSF Alone Versus G-CSF Plus GM-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's 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)
Primary Objectives: 1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups. 2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups. Secondary Objectives: 1. To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging. 2. To determine the incidence of disease progression/relapse at 12 months in the two groups.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apheresis | Procedure | — | UNRESOLVED |
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| GM-CSF | Drug | — | UNRESOLVED |
| Isophosphamide | Drug | Ifosfamide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
- description
- Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
- interventionNames
- Drug: Etoposide
- Drug: G-CSF
- Drug: GM-CSF
- Drug: Isophosphamide
- Drug: Rituximab
- Procedure: Apheresis
- type
- EXPERIMENTAL
- label
- Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
- description
- Growth Factor = granulocyte-colony stimulating factor (G-CSF)
- interventionNames
- Drug: Etoposide
- Drug: G-CSF
- Drug: Isophosphamide
- Drug: Rituximab
- Procedure: Apheresis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma who are candidates for autologous stem cell transplantation. 2. Age up to 70 years 3. Platelet count \> 100,000 mm3, independent of transfusion support 4. Absolute neutrophil count (ANC) \> 1500/mm3 5. Zubrod performance status of 2 or less. 6. Negative pregnancy test in women 7. Less than 10% marrow involvement with lymphoma within 4 weeks of study enrollment as defined by bilateral bone marrow aspirations and biopsies. 8. Should be seronegative for HIV, HTLV, hepatitis B surface antigen, hepatitis C antibody. Exclusion Criteria: 1. Clinical or radiographic evidence of active CNS disease 2. Severe concomitant medical or psychiatric illness 3. Lactating or breast feeding females 4. Less than 3 weeks from the first day of last chemotherapy 5. Prior myeloablative therapy with autologous bone marrow or stem cell rescue 6. Serum bilirubin \> 1.5 X ULN, Serum transaminases \> 2XULN. 7. Serum creatinine \>1.6 mg/dl 8. History of pelvic radiation 9. Patients should not have received more than 3 prior chemotherapy regimens (excluding radiation) 10. Patients should not have received more than 6 cycles of fludarabine therapy
References
Publications (1)
- DERIVEDHosing C, Munsell MF, Reuben JM, Popat U, Lee BN, Gao H, Korbling M, Shpall EJ, Kebriaei P, Alousi A, De Lima M, McMannis J, Qazilbash M, Anderlini P, Giralt S, Champlin RE, Khouri I. A randomized study comparing chemotherapy followed by G-CSF alone or in combination with GM-CSF for mobilization of peripheral blood stem cells in patients with non-Hodgkin's lymphomas. J Blood Med. 2010;1:49-55. doi: 10.2147/JBM.S9846. Epub 2010 Apr 14. PMID 22282683