Non-Hodgkin's Lymphoma Clinical Trial
Official title:
A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's Lymphoma
This study will determine the efficacy of clofarabine as measured by response rate in patients with aggressive non-Hodgkin's lymphoma
Rationale: Two Food and Drug Administration drugs approved for blood cancers such as
non-Hodgkin's lymphoma (NHL) include fludarabine (Fludara) and cladribine (Leustat). The drug
offered in the current study, clofarabine was designed to combine the anti-cancer strength of
both fludarabine and cladribine. Laboratory research suggests that clofarabine targets
anti-cancer mechanisms in cells, helps repair DNA, and inhibits tumor growth. Research also
indicates that clofarabine has some efficacy against a variety of blood cancers and solid
tumors. Numerous tumor responses have been observed with high doses of clofarabine in heavily
pretreated patients with different types of lymphoma. The current study build on this
previous research to test clofarabine in patients with aggressive NHL.
Purpose: This study will evaluate the safety and efficacy of clofarabine for aggressive NHL.
Toxicities resulting from the combination of clofarabine and the supportive care drug GM-CSF
will also be analyzed in patients. GM-CSF is a blood-forming agent that stimulates the
production of white blood cells. In addition, several tests, including blood and tumor tissue
analysis, will assess immune response and biological changes to the tumor as a result of
study drugs.
Treatment: Patients in this study will be given clofarabine through intravenous infusions.
This drug will initially be provided to patients for five consecutive days. Several tests
will then be conducted and supportive care agents will be administered to stabilize patients'
blood cell counts, immune response, and reduce the risk of infection. The first ten patients
in this study will be hospitalized until recovery from the first five days of clofarabine to
carefully monitor any additional toxicities resulting from the dosing regimen. Patients will
receive another five day treatment cycle with clofarabine within seven days after recovering
from each previous cycle and no more than four weeks from the start of the previous cycle.
Disease response will be measured after every two cycles of treatment with clofarabine.
Patient with stable or reduced disease will receive a maximum of six treatment cycles with
clofarabine. Treatments will be discontinued due to disease growth, unacceptable side
effects, or a treatment delay of more than 21 days.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT01878890 -
Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.
|
Phase 1 | |
| Completed |
NCT04152148 -
A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients
|
Phase 1 | |
| Recruiting |
NCT05096234 -
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
|
Phase 2 | |
| Recruiting |
NCT05191225 -
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
|
Phase 4 | |
| Recruiting |
NCT05623982 -
Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03664635 -
MB-CART20.1 Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
| Terminated |
NCT01699581 -
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT01763398 -
Analysis of the Risk Factors for the Neutropenic Fever in the High Risk NHL Patients for Developing Febrile Neutropenia Who Received 3-weekly CHOP-like Chemotherapy With Primary G-CSF Prophylaxis; Prospective Multicenter Observation Study
|
N/A | |
| Completed |
NCT01205503 -
Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
|
Phase 2 | |
| Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
| Completed |
NCT00969462 -
Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
|
Phase 4 | |
| Completed |
NCT00659425 -
CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Terminated |
NCT00475332 -
Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar
|
Phase 2 | |
| Completed |
NCT00608907 -
An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)
|
Phase 1 | |
| Completed |
NCT00533728 -
Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT00577161 -
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
|
Phase 3 | |
| Completed |
NCT00430352 -
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
|
Phase 4 | |
| Completed |
NCT00581646 -
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
|
N/A |