Clinical Trials Logo
  1. Home
  2. Chronic Lymphocytic Leukemia
  3. NCT00093314
  4. Details
NCT00093314 Clinical Trial

HuMax-CD20 in Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
An Open-labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00093314
Other study ID # Hx-CD20-402
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received October 6, 2004
Last updated April 20, 2015
Start date October 2004
Est. completion date January 2007

Study information
Verified date January 2007
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chronic Lymphocytic Leukemia

- Circulating lymphocytes above a specific level

- Circulating lymphocytes showing certain markers

Exclusion Criteria:

- Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study.

- Previous stem cell transplantation.

- Received any of the following treatments within 4 weeks prior to entering this trial: A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C) Radiotherapy.

- HIV positivity.

- Hepatitis B or hepatitis C.

- Other cancerous diseases, except certain skin cancers and cervix cancer.

- Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases.

- Participation in another trial with a different new drug 4 weeks prior to enrollment in study.

- Current participation in any other clinical study.

- Pregnant or breast-feeding women.

- Women of childbearing age who are unable or unwilling to use adequate contraception.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• HuMax-CD20

Locations
Country Name City State
United States University of Iowa, Hospitals and Clinics Iowa City Iowa

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Enrolling by invitation NCT01804686 - A Long-term Extension Study of PCI-32765 (Ibrutinib) Phase 3
Completed NCT02057185 - Occupational Status and Hematological Disease
Active, not recruiting NCT04240704 - Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL Phase 1
Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Active, not recruiting NCT03280160 - Protocol GELLC-7: Ibrutinib Followed by Ibrutinib Consolidation in Combination With Ofatumumab Phase 2
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT00038025 - A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT02231853 - Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections Phase 1
Recruiting NCT05417165 - Anti-pneumococcal Vaccine Strategy in Patients With Chronic Lymphocytic Leukemia Phase 2
Recruiting NCT04028531 - Understanding Chronic Lymphocytic Leukemia
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Completed NCT02910583 - Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) Phase 2
Completed NCT01527045 - Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies Phase 2
Recruiting NCT04679012 - Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation Phase 2
Recruiting NCT05405309 - RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia Phase 1/Phase 2
Active, not recruiting NCT05023980 - A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Phase 3
Recruiting NCT04553692 - Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers Phase 1
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer