Hematologic MalignanciesPhase 2NCT01622556
Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies
A Phase 2 study testing Fludarabine, Busulfan and Thymoglobulin in people with Hematologic Malignancies, run by University of Virginia at 1 site in United States.
Trial summary
This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Fludarabine, Busulfan and Thymoglobulin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2017
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18-70 years old. ECOG 0-2
- Patients must have a diagnosis of one of the following:
- Chronic Myeloid Leukemia
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Hodgkin's Disease
Show all 12Show fewer
- Non-Hodgkins Lymphoma
- Myelodysplastic Syndromes
- Myeloproliferative Disorder
- Patients must have adequate visceral organ function
- Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
- Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.
Who cannot join
- Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good health who is willing to donate stem cells are ineligible.
- Patients who are pregnant are ineligible.
- Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
- Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies
This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.
- Conditions
- Hematologic Malignancies
- Being tested
- Fludarabine, Busulfan, Thymoglobulin, Total Body Irradiation, Umbilical Cord Blood
- Keywords
- Chronic Myeloid Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Hodgkin's Disease, Myelodysplastic Syndromes, Myeloproliferative Disorder
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
35 mg/m2 IV/day x 5 days
BusulfanDrug
.8 mg/kg IV Q6h x 8 doses
ThymoglobulinDrug
1.5 mg/kg/day x 3 days
Total Body IrradiationRadiation
150 cGy for 2 days
Umbilical Cord BloodBiological
Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Intensity Conditioning with UCB Transplant | Experimental | Not described Receives: Drug: Fludarabine; Drug: Busulfan; Drug: Thymoglobulin; Radiation: Total Body Irradiation; Biological: Umbilical Cord Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Number of subjects surviving with no events at 180 days post transplantation (Day 0).
Measured: 180 days
Secondary outcomes (7)
Transplant Engraftment
Number of patients with successful UCB engraftment.
Measured: Day 42
Incidence of Graft-versus-host disease (GVHD)
Number of patients that experience acute or chronic GVHD.
Measured: 1 year
Time course for peripheral blood chimerism.
Percent of patients with >95% donor chimerism.
Measured: 56 days
Incidence of secondary lymphoproliferative diseases
Number of patients with secondary lymphoproliferative diseases.
Measured: 6 months
Incidence of disease recurrence
Number of patients experience disease recurrence.
Measured: Up to two years
Incidence of serious infectious complications
Number of patients experiencing serious infectious complications.
Measured: 1 year
Overall Survivals
Number of patient with overall event free survival and overall survival distributions.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2014 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amer Beitinjaneh, MD, University of Virginia
- Investigators
- Amer M Beitinjaneh, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622556
- Sponsor's protocol ID
- 15954 UCB-2011
- Status last verified
- Feb 2014
- First submitted
- 8 Jun 2012
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01622556
- Acronym / sponsor ID
- 15954 UCB-2011
- Conditions
- Hematologic Malignancies
- Keywords
- Chronic Myeloid Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkins Lymphoma, Hodgkin's Disease, Myelodysplastic Syndromes, Myeloproliferative Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 19 Jun 2012 (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.
This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced Intensity Conditioning with UCB Transplant | Experimental | Drug: Fludarabine, Drug: Busulfan, Drug: Thymoglobulin, Radiation: Total Body Irradiation, Biological: Umbilical Cord Blood |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects 18-70 years old. ECOG 0-2
- Chronic Myeloid Leukemia
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Hodgkin's Disease
Key exclusion criteria (4 listed)
- Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good health who is willing to donate stem cells are ineligible.
- Patients who are pregnant are ineligible.
- Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
- Patients who are HIV or HTLV-I, -II antibody sero-positive are ineligible.
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 |
|---|---|---|
| Fludarabine35 mg/m2 IV/day x 5 days | Drug | Reduced Intensity Conditioning with UCB Transplant |
| Busulfan.8 mg/kg IV Q6h x 8 doses | Drug | Reduced Intensity Conditioning with UCB Transplant |
| Thymoglobulin1.5 mg/kg/day x 3 days | Drug | Reduced Intensity Conditioning with UCB Transplant |
| Total Body Irradiation150 cGy for 2 days | Radiation | Reduced Intensity Conditioning with UCB Transplant |
| Umbilical Cord BloodTwo partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient. | Biological | Reduced Intensity Conditioning with UCB Transplant |
Primary outcome
Event Free Survival
Time frame: 180 days
Number of subjects surviving with no events at 180 days post transplantation (Day 0).
7 secondary outcomes
Transplant Engraftment
Time frame: Day 42
Incidence of Graft-versus-host disease (GVHD)
Time frame: 1 year
Time course for peripheral blood chimerism.
Time frame: 56 days
Incidence of secondary lymphoproliferative diseases
Time frame: 6 months
Incidence of disease recurrence
Time frame: Up to two years
Incidence of serious infectious complications
Time frame: 1 year
Overall Survivals
Time frame: 60 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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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.
Amer M Beitinjaneh, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, Busulfan and Thymoglobulin in people with Hematologic Malignancies, run by University of Virginia 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?
The sponsor lists 12 inclusion and 4 exclusion criteria. 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: stopped early, as of the sponsor's last update on 11 Feb 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Event Free Survival (time frame: 180 days). 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 11 Feb 2014.