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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01538472
Recruitment Status : Completed
First Posted : February 24, 2012
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Y Zevalin, BEAM and Rituximab In Autologous Stem Cell Transplantation (ASCT) For Lymphoma
Study Start Date : September 2003
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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
  • 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea

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

Primary Outcome Measures :
  1. Overall Survival Median [ Time Frame: Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration) ]
    Overall survival reported as number of days participants alive following treatment up to 5 years with annual follow up till disease progression. Evaluations 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.

  2. 3-Year Overall Survival [ Time Frame: 3 years ]
    Number of participants alive 3 years following treatment. Evaluations done every 3 months for 1 year and then every 6 months to check on the status of the disease.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01538472

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01538472     History of Changes
Other Study ID Numbers: ID03-0123
First Posted: February 24, 2012    Key Record Dates
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014
Last Verified: September 2014
Keywords provided by M.D. Anderson Cancer Center:
Relapse B-cell CD20+ non-Hodgkin's lymphoma
High-dose BEAM chemotherapy
Y Zevalin
In Zevalin
1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea
Cytosine Arabinosine Hydrochloride
Stem cell infusion
Autologous stem cell transplantation
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Adjuvants, Immunologic
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists