Trial · NCT00047060
Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome
NCT00047060, Phase 1, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2020-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome. Trials, record NCT00047060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00047060
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stem Cell Transplant Therapy With Campath-1H for Treating Advanced Mycosis Fungoides and Sezary Syndrome
- NCT number
- NCT00047060
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Mycosis Fungoides, Sezary Syndrome
- Interventions
- A matched peripheral donor stem cells, cyclosporine, fludarabine, Campath
- First posted
- 2003-01-27
- Last updated
- 2023-11-14
- Results first posted
- 2020-02-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Nonmyeloablative Preparative Regimen | 36 months | Proportion of subjects achieving a complete response. Complete response (CR) is defined as: disappearance of all signs and symptoms of cutaneous T-cell lymphomas (CTCL) for a period of at least one month. |
| Secondary | Number of Participants Who Experienced Acute GVHD Grades II-IV | up to 100 days | Number of participants who experienced acute GVHD grades II-IV Acute-GVHD was graded and staged prospectively using criteria from the 1994 Consensus Conference on Acute- GVHD Grading. Grades are defined as: Grade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day. Grade III: Skin = Rash on \>50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea \> 1500 mL/day. Grade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin \>15 mg/dL; Lower GI = Severe abdominal pain with or without ileus. Grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. |
| Secondary | Number of Participant Who Experienced Chronic Graft Versus Host Disease | Day 100 up to 3 years | Number of participant who experienced chronic graft versus host disease (GVHD) following stem cell transplant The diagnosis of clinical features of chronic-GVHD was determined prospectively and classified retrospectively into limited or extensive based on the Revised Seattle Classification. Chronic GvHD severity categorized as "limited" is defined as: localized skin lesions with or without limited hepatic involvement and "extensive" is defined as: generalized skin involvement, major hepatic complications, or involvement of any other organ. |
| Secondary | Number of Participants That Experienced Graft Failure | up to 100 days | Number of participants that experienced graft failure. Graft failure is defined as: the failure to achieve sustained engraftment following stem cell transplantation. |
| Secondary | Overall Response | Up to 3 years | Overall response following stem cell transplant. Complete response (CR) is defined as: disappearance of all signs and symptoms of cutaneous T-cell lymphomas (CTCL) for a period of at least one month. Partial response (PR) - a 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions (a greater than 50% reduction in area of disease involvement in the case of cutaneous disease) lasting for a period of at least one month. No new metastatic lesions may appear. Stable disease is defined as: tumor measurements not meeting the criteria of CR, PR, or PD. Progressive disease (PD) - increase of 25% or greater in the sum of the products of the longest perpendicular diameters of all measured lesions (a greater than 25% increase in area of disease involvement in the case of cutaneous disease) compared to the smallest previous measurements, or the development of any new metastatic or cutaneous disease. |
| Secondary | Number of Participants Who Experienced Transplant Related Mortality | day 100 | Number of Participants who experienced transplant related mortality by day 100 |
| Secondary | Number of Participants Overall Survival | up to 5 years | Number of participants overall survival following stem cell transplant. Overall survival is defined as number participants alive following stem cell transplant |
| Secondary | Number of Participants That Remained Disease-free | up to 100 days | Number of participants that remained Disease-free survival following stem cell transplant. Disease-free survival is defined as survival free of disease relapse or disease progression following stem cell transplant. |
| Secondary | Number of Participants That Experienced Engraftment | up to 100 days | Number of participants that experienced engraftment following stem cell transplant. Engraftment is defined as neutrophil count is greater than 0.5 x10\^9. |
| Secondary | Number of Participants That Experienced Platelet Recovery | up to 100 days | Number of participants that experienced platelet recovery up to day 100 following stem cell transplant. Platelet recovery is defined as platelet count is greater than 50 x 10\^9/l without platelet transfusion. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Nonmyeloablative Preparative Regimen | 36 months | Received a nonmyeloablative preparative regimen of alemtuzumab 30mg IV 3x a week for 2 weeks followed by fludarabine 25mg/m\^2/day for five days followed by a PBPC graft targeted to deliver ≥ 5x10\^6 CD34+ cells/kg. Cyclosporine A (CSA) for GVHD prophylaxis will be used initially w/target CSA levels in the therapeutic range (200 -400 ng/ml). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced Acute GVHD Grades II-IV | up to 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participant Who Experienced Chronic Graft Versus Host Disease | Day 100 up to 3 years | The analyses included only those participants that engrafted and survived over 100 days | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Experienced Graft Failure | up to 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Response | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Experienced Transplant Related Mortality | day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Overall Survival | up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Remained Disease-free | up to 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Experienced Engraftment | up to 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Experienced Platelet Recovery | up to 100 days | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Nonmyeloablative Preparative Regimen | Stem Cell Transplant Therapy With Campath-1H | 4 | Participants | ||
| Number of Participants Who Experienced Acute GVHD Grades II-IV | Stem Cell Transplant Therapy With Campath-1H | Grade II | 0 | Participants | |
| Number of Participants Who Experienced Acute GVHD Grades II-IV | Stem Cell Transplant Therapy With Campath-1H | Grade III-IV | 1 | Participants | |
| Number of Participant Who Experienced Chronic Graft Versus Host Disease | Stem Cell Transplant Therapy With Campath-1H | Limited | 3 | Participants | |
| Number of Participant Who Experienced Chronic Graft Versus Host Disease | Stem Cell Transplant Therapy With Campath-1H | Extensive | 0 | Participants | |
| Number of Participants That Experienced Graft Failure | Stem Cell Transplant Therapy With Campath-1H | 0 | Participants | ||
| Overall Response | Stem Cell Transplant Therapy With Campath-1H | Complete Response (CR) | 4 | Participants | |
| Overall Response | Stem Cell Transplant Therapy With Campath-1H | Stable Disease | 1 | Participants | |
| Overall Response | Stem Cell Transplant Therapy With Campath-1H | Partial response (PR) | 0 | Participants | |
| Overall Response | Stem Cell Transplant Therapy With Campath-1H | Progressive disease (PD) | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stem Cell Transplant Therapy With Campath-1H | 5 | |
| Overall Study | COMPLETED | Stem Cell Transplant Therapy With Campath-1H | 3 | |
| Overall Study | NOT COMPLETED | Stem Cell Transplant Therapy With Campath-1H | 2 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Febrile Neutropenia | Blood and lymphatic system disorders | Stem Cell Transplant Therapy With Campath-1H | 1 | 5 | |
| serious | Eyelid disorder | Eye disorders | Stem Cell Transplant Therapy With Campath-1H | 1 | 5 | |
| serious | Abdominal pain | Gastrointestinal disorders | Stem Cell Transplant Therapy With Campath-1H | 1 | 5 | |
| serious | Vomiting | Gastrointestinal disorders | Stem Cell Transplant Therapy With Campath-1H | 1 | 5 | |
| serious | Disease Progression | General disorders | Stem Cell Transplant Therapy With Campath-1H | 2 | 5 | |
| serious | Fatigue | General disorders | Stem Cell Transplant Therapy With Campath-1H | 1 | 5 | |
| serious | Pain | General disorders | Stem Cell Transplant Therapy With Campath-1H | 2 | 5 | |
| serious | Acute graft versus host disease | Immune system disorders | Stem Cell Transplant Therapy With Campath-1H | 1 | 5 | |
| serious | chronic graft versus host disease | Immune system disorders | Stem Cell Transplant Therapy With Campath-1H | 1 | 5 | |
| serious | Candida infection | Infections and infestations | Stem Cell Transplant Therapy With Campath-1H | 1 | 5 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stem Cell Transplant Therapy With Campath-1H | 2 | 5 |
| Total, other adverse events | Stem Cell Transplant Therapy With Campath-1H | 0 | 5 |
| Total, serious adverse events | Stem Cell Transplant Therapy With Campath-1H | 5 | 5 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00047060
GET https://conductscience.org/api/trials/v1/NCT00047060/events?page=2