Y Zevalin and BEAM in Autologous Stem Cell Transplantation (ASCT) for Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01538472
First received: February 20, 2012
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells is safe. Another goal is to learn if this treatment can help decrease the chances of the cancer coming back.


Condition Intervention Phase
Lymphoma
Drug: Y Zevalin
Drug: In Zevalin
Drug: Rituxan
Drug: BCNU
Drug: VP -16
Drug: Ara-C
Drug: Melphalan
Procedure: Stem Cell Infusion
Drug: G-CSF
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Y Zevalin, BEAM and Rituximab In Autologous Stem Cell Transplantation (ASCT) For Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Median Overall Survival [ Time Frame: 8 years (study duration) ] [ Designated as safety issue: No ]
    Number of participants alive following treatment at 5 years then annual follow up till disease progression. Evaulations done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease, with long-term follow up as needed.


Enrollment: 40
Study Start Date: September 2003
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Y Zevalin + BEAM

Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.

G-CSF 5 mg/kg given daily starting Day 0 till recovery of granulocytes of 4.0 * 109/L.

Drug: Y Zevalin
Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14.
Drug: In Zevalin
Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21.
Drug: Rituxan

250 mg/m2 by vein on Day -21 and on Day -14.

1000 mg/m2 by vein on Days +1 and +8.

Other Name: Rituximab
Drug: BCNU
300 mg/m2 by vein on Day -6.
Other Names:
  • Carmustine
  • BiCNU
Drug: VP -16
200 mg/m2 by vein every 12 hours on Days -5, -4, -3, and -2.
Drug: Ara-C
200 mg/m2 by vein every 12 hours on Days -5, -4, -3,and -2.
Other Names:
  • Cytarabine
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride
Drug: Melphalan
140 mg/m2 by vein on Day -1.
Other Name: Alkeran
Procedure: Stem Cell Infusion
Autologous stem cell infusion on Day 0.
Drug: G-CSF
5 mg/kg by vein daily starting Day 0 till recovery of granulocytes of 4.0 x 109/L.
Other Names:
  • Filgrastim
  • Neupogen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Relapsed CD20-positive B-cell non-Hodgkin's lymphoma (NHL) (demonstrated in lymph nodes or bone marrow), chemosensitive (at least Partial Remission [PR]).
  2. No anti-cancer therapy started within three weeks, prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy. No prior Rituximab within three weeks of starting therapy.
  3. No prior radioimmunoconjugate therapy.
  4. If patients had prior radiation, this should have not involved more than 25% of the bone marrow.
  5. An IRB-approved signed informed consent.
  6. Age: 18 to 65 years of age.
  7. Acceptable hematologic status within two weeks prior to patient registration, including: Absolute neutrophil count ([segmented neutrophils + bands] * total white blood count [WBC]) > 1,500/mm3. Platelet counts > 100,000/mm3.
  8. Patients determined to have <10% bone marrow involvement with lymphoma within four weeks before stem cell collection as defined by bilateral aspirates and biopsies.
  9. Prestudy performance status of 0, 1, or 2 according to the World Health Organization (WHO).
  10. Female patients included must not be pregnant or lactating.
  11. Men and women or reproductive potential who are following acceptable birth control methods (as determined by the treating physician, however abstinence is not an acceptable method).
  12. Patients who have previously been treated on Phase II drugs can be included if no long-term toxicity is expected, and the patient has been off the drug for four or more weeks with no significant post treatment toxicities observed
  13. Patients should have at least 4 * 106 CD34+/kg peripheral stem cells collected. Whenever possible, 1 to 2 * 106 CD34+/kg, for the first 10 patients and held for 1 year in case of graft failure. If graft failure does not occur in the first 10 patients, backup cells will not be required for subsequent patients.

Exclusion Criteria:

  1. Patients with impaired bone marrow reserve, as indicated by one or more of the following: Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue Platelet count < 100,000 cells/mm3 Hypocellular bone marrow Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid) History of failed stem cell collection of > 4*106 CD34+/kg
  2. Prior radioimmunotherapy.
  3. Presence of central nervous system (CNS) lymphoma.
  4. Patients with chronic lymphocytic lymphoma.
  5. Patients with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related lymphoma.
  6. Patients with abnormal liver function: total bilirubin > 1.5 mg/dl
  7. Patients with abnormal renal function: serum creatinine > 1.6 mg/dl
  8. Patients who have received prior external beam radiation therapy to >25% of active bone marrow (involved field or regional).
  9. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  10. Corrected carbon monoxide diffusion in the lung (DLCO) <50% and forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 50% predicted.
  11. Cardiac ejection fraction (EF) < 50% by 2-D Echogram.
  12. Pleural effusions.
  13. Prior radiation to lungs.
  14. Abnormal cytogenetics, filter in situ hybridization (FISH) (-5, -7, 11q23)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538472

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Biogen Idec
Investigators
Principal Investigator: Issa F. Khouri, MD,BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01538472     History of Changes
Other Study ID Numbers: ID03-0123
Study First Received: February 20, 2012
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Relapse B-cell CD20+ non-Hodgkin's lymphoma
High-dose BEAM chemotherapy
Y Zevalin
In Zevalin
Rituxan
Rituximab
BCNU
Carmustine
BiCNU
VP-16
Ara-C
Cytarabine
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride
Melphalan
Alkeran
G-CSF
Filgrastim
Neupogen
Stem cell infusion
Autologous stem cell transplantation

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Carmustine
Melphalan
Rituximab
Cytarabine
Etoposide
Lenograstim
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Myeloablative Agonists
Adjuvants, Immunologic
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014