Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma
Role of Rituximab Containing Salvage Chemotherapy and in Vivo Purging in Obtaining PCR Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma or Transplant Eligible Mantle Cell Lymphoma
Panoramica dello studio
Descrizione dettagliata
Following the first relapse, patients with follicular type of Non-Hodgkin's lymphoma may have an option to receive high dose chemotherapy followed by autologous (from you) blood stem cell transplantation. One of the common causes of relapse is persistence of lymphoma cells in the bone marrow and in the collected stem cell products.
Patients who do not have a complete response after traditional chemotherapy, have a greater chance of the lymphoma returning even after receiving high dose chemotherapy with stem cell transplantation. In order to improve the response and decrease the relapse rate, additional therapy may be used to kill the lymphoma cells by using antibodies both before and after the transplantation. Antibodies are protein made by white cells in our body to fight off infection and sometimes tumor. Rituxan (rituximab) is an antibody that is effective against your type of lymphoma. Researchers have reported that patients show an improved response and a lower chance of relapse when using rituximab with high dose chemotherapy with autologous stem cell transplantation. It is unknown how effective rituximab is in clearing persistence of minimal remaining disease in patients with follicular lymphoma.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Kansas
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Kansas City, Kansas, Stati Uniti, 66160
- University of Kansas Medical Center
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Kansas City, Kansas, Stati Uniti, 66205
- University of Kansas Medical Center, Westwood Campus
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20) Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete remission 1) or later.
- Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow negative disease.
- Patients planning to harvest and hold may also be included as long as above criteria are met.
Exclusion Criteria:
- Pregnancy
- Zubrod performance status greater than 2
- Life expectancy is severely limited by concomitant illness.
- Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation
- Symptomatic pulmonary disease precluding transplantation
- Serum creatinine greater than 1.8 mg/dL
- Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate transaminase) greater than 3 times upper limit of normal
- Evidence of chronic active hepatitis or cirrhosis
- Unable to sign informed consent.
- Allergy to Rituximab
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Rituximab
Patients will be treated IV with rituximab at the rate of 50 milligrams per hour (mg/hour) for 1 hour.
If patient tolerates the infusion, the rate is increased by increments of 50 mg/hour every 30 minutes to a maximum of 400 mg/hour.
If patient has a severe reaction, the infusion is stopped temporarily and the infusion rate is decreased by 50%.
Subsequent infusions are started at the rate of 100 mg/hour, increased by 100 mg/hour every 30 minutes to a maximum of 400 mg/hour if tolerated.
Vital signs are monitored every 15 minutes for 2 hours and every 30 minutes thereafter.
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375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Rate of PCR Negativity
Lasso di tempo: up to 7 days
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Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.
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up to 7 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Progression Free Survival (PFS) and Overall Survival (OS)
Lasso di tempo: up to 60 months
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Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease.
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up to 60 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Siddhartha Ganguly, MD, University of Kansas Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma non Hodgkin
- Linfoma
- Linfoma, follicolare
- Effetti fisiologici delle droghe
- Agenti antireumatici
- Agenti antineoplastici
- Fattori immunologici
- Agenti antineoplastici, immunologici
- Rituximab
Altri numeri di identificazione dello studio
- 11571
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