Chronic Myeloproliferative DisordersNCT00068523
Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
A study testing anti-thymocyte globulin, cyclophosphamide and cyclosporine in people with Chronic Myeloproliferative Disorders and Leukemia, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
- What is being tested?
- anti-thymocyte globulin, cyclophosphamide and cyclosporine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) meeting any of the following criteria:
- First complete remission with high-risk karyotype
- Translocations t(15;17) allowed only if failed first-line induction therapy OR molecular evidence of persistent disease exists
- Translocations t(8;21) and inv(16) allowed only if failed first-line induction therapy
- Second or subsequent complete remission
- Minimal residual disease*
- Acute lymphoblastic leukemia meeting any of the following criteria:
- Failed induction therapy and has minimal residual disease* by salvage therapy
- First complete remission with high-risk karyotype (e.g., t[4;11] or t[9;22])
- Relapsed disease allowed provided a second or subsequent complete remission or minimal residual disease* is achieved
- Chronic myelogenous leukemia meeting any of the following criteria:
- Persistent or relapsed disease after 1 year of imatinib mesylate therapy
- Accelerated phase or blast crisis
- Blast crisis allowed after reinduction chemotherapy places disease in chronic phase
- Myelodysplastic syndromes meeting any of the following criteria:
- Refractory to medical management
- Cytogenetic abnormalities predictive of transformation into acute leukemia, including 5q-, 7q-, monosomy 7 and trisomy 8, or evidence of evolution to AML (e.g., refractory anemia with excess blasts (RAEB) or RAEB in transformation)
- Non-Hodgkin's lymphoma or Hodgkin's lymphoma meeting any of the following criteria:
- Beyond first complete remission or failed primary induction therapy and demonstrated sensitivity to therapy during the 6 months before transplantation
- Recurrent disease after autologous stem cell transplantation
- Must be at least 3 months posttransplantation
- Cyclin D1+ mantle cell lymphoma allowed after induction therapy and in first remission
- Multiple myeloma meeting either of the following criteria:
- Refractory or relapsed disease
- Residual disease after autologous transplantation
- Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:
- Peripheral blood absolute lymphocyte count greater than 5,000/mm^3
- Small to moderate size lymphocytes and less than 55% pro-lymphocytes, atypical lymphocytes, or lymphoblasts morphologically
- B-cell or T-cell
- Myeloproliferative disorders, including myelofibrosis
- Philadelphia negative
- Availability of a HLA-A, B, and DR identical family donor OR HLA-A, B, and DR genetically matched unrelated donor
- Must meet 1 of the following criteria:
- At least 55 years of age at time of transplantation
- Received extensive prior therapy (i.e., more than 1 year of alkylator therapy or more than 2 different prior salvage regimens) or stem cell transplantation with myeloablative conditioning (either autologous or allogeneic)
- Presenting with comorbid condition (e.g., abnormal cardiac, pulmonary, or renal function and/or prior life-threatening infection) that precludes eligibility for enrollment in allogeneic transplantation protocols with full ablation conditioning
- No active CNS disease NOTE: *Defined as having no circulating blasts, absolute neutrophil count greater than 1,000/mm3 and less than 10% blasts in bone marrow at least 3 weeks after last systemic chemotherapy
PATIENT CHARACTERISTICS:
Age
- See Disease Characteristics
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- ALT/AST no greater than 4 times normal
Renal
- See Disease Characteristics
- Creatinine less than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- See Disease Characteristics
- Normal cardiac function by echocardiogram or radionuclide scan
- Shortening fraction or ejection fraction at least 40% of normal
Pulmonary
- See Disease Characteristics
- DLCO at least 60%
- FEV_1 greater than 50% of predicted
- Pulse oximetry greater than 85%
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No uncontrolled active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 2 weeks since prior biologic response modifiers, signal transduction inhibitors, or monoclonal antibodies
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior systemic conventional chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Recovered from prior therapy
- No concurrent sun block/sunscreen or any cosmetic that may act as a sunscreen (e.g., lotion with SPF) on the days of scheduled ultraviolet-B light therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Ultraviolet-B light therapy given before and after allogeneic stem cell transplantation may help prevent this from happening.
PURPOSE: Clinical trial to study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety of ultraviolet-B light therapy and allogeneic peripheral blood stem cell transplantation in patients with hematologic malignancies by demonstrating 100-day mortality no greater than 15% and 1-year mortality no greater than 40%.
- Determine the frequency of treatment-related toxicity leading to death and frequency of disease relapse resulting in death in patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
Secondary
- Determine the rates of donor allogeneic hematologic engraftment in patients treated with this regimen.
- Determine the rate and quality of immune reconstitution in the peripheral blood and the composition of immune cells in the skin before and after transplantation in these patients.
- Determine the event-free and overall survival of patients treated with this regimen.
OUTLINE:
- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 to -2. Patients also receive anti-thymocyte globulin IV over 4 hours on days -2 to -1. Patients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.
- Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days -1 to 100 and methylprednisolone (oral or IV) on days 5-15.
- Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly on weeks 2-4.
Donor lymphocyte infusion is performed per institutional guidelines for patients in whom emerging donor chimerism post allogeneic PBSC transplantation is not progressing (consistently below 50% during first 3 months), for whom donor chimerism is receding (to below 25%) despite cessation of cyclosporine, or who relapse within 24 months after allografting.
Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: A total of 23-36 patients will be accrued for this study.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
- Being tested
- anti-thymocyte globulin, cyclophosphamide, cyclosporine, fludarabine phosphate, methylprednisolone
- Keywords
- refractory multiple myeloma, accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, blastic phase chronic myelogenous leukemia, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, refractory chronic lymphocytic leukemia, relapsing chronic myelogenous leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myeloid, Accelerated Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinBiological
anti-thymocyte globulin IV over 4 hours on days -2 to -1
cyclophosphamideDrug
cyclophosphamide IV over 1 hour on days -3 to -2
cyclosporineDrug
oral cyclosporine on days -1 to 100
fludarabine IV over 30 minutes on days -8 to -4
methylprednisolone (oral or IV) on days 5-15
UV light therapyProcedure or surgery
Patients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days. Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly on weeks 2-4.
allogeneic bone marrow transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.
Measured: Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2003 (estimated)
- Study startJun 2003
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Omer N. Koc, MD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068523
- Sponsor's protocol ID
- ICC7Y02
- Status last verified
- Jul 2020
- First submitted
- 10 Sep 2003
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00068523
- Acronym / sponsor ID
- ICC7Y02
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
- Keywords
- refractory multiple myeloma, accelerated phase chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, blastic phase chronic myelogenous leukemia, recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, refractory chronic lymphocytic leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Mar 2004 (actual)
- First posted
- 11 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Ultraviolet-B light therapy given before and after allogeneic stem cell transplantation may help prevent this from happening.
PURPOSE: Clinical trial to study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.
Detailed description
OBJECTIVES:
Primary
- Determine the safety of ultraviolet-B light therapy and allogeneic peripheral blood stem cell transplantation in patients with hematologic malignancies by demonstrating 100-day mortality no greater than 15% and 1-year mortality no greater than 40%.
- Determine the frequency of treatment-related toxicity leading to death and frequency of disease relapse resulting in death in patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
Secondary
- Determine the rates of donor allogeneic hematologic engraftment in patients treated with this regimen.
- Determine the rate and quality of immune reconstitution in the peripheral blood and the composition of immune cells in the skin before and after transplantation in these patients.
- Determine the event-free and overall survival of patients treated with this regimen.
OUTLINE:
- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 to -2. Patients also receive anti-thymocyte globulin IV over 4 hours on days -2 to -1. Patients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0.
- Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days -1 to 100 and methylprednisolone (oral or IV) on days 5-15.
- Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly on weeks 2-4.
Donor lymphocyte infusion is performed per institutional guidelines for patients in whom emerging donor chimerism post allogeneic PBSC transplantation is not progressing (consistently below 50% during first 3 months), for whom donor chimerism is receding (to below 25%) despite cessation of cyclosporine, or who relapse within 24 months after allografting.
Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.
PROJECTED ACCRUAL: A total of 23-36 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-thymocyte globulinanti-thymocyte globulin IV over 4 hours on days -2 to -1 | Biological | – |
| cyclophosphamidecyclophosphamide IV over 1 hour on days -3 to -2 | Drug | – |
| cyclosporineoral cyclosporine on days -1 to 100 | Drug | – |
| fludarabine phosphatefludarabine IV over 30 minutes on days -8 to -4 | Drug | – |
| methylprednisolonemethylprednisolone (oral or IV) on days 5-15 | Drug | – |
| UV light therapyPatients undergo ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total of 3 days. Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly on weeks 2-4. | Procedure or surgery | – |
| allogeneic bone marrow transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantationAllogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0. | Procedure or surgery | – |
Primary outcome
Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.
Time frame: Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer N. Koc, MD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-thymocyte globulin, cyclophosphamide and cyclosporine in people with Chronic Myeloproliferative Disorders and Leukemia, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies. (time frame: Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.